{ "release_id": "fc5a600ec7387e71", "id": "maternal:cafcit", "owner": "maternal", "kind": "product", "slug": "cafcit", "name": "Cafcit (caffeine citrate)", "aliases": [ "CAFCIT" ], "atlases": [ "maternal" ], "summary_plain": "Cafcit is the brand name that FDA's Drugs@FDA data give to caffeine citrate under application NDA020793: an intravenous solution that is prescription-marketed, and an oral solution that is listed as discontinued. The current US label read for this record is titled Caffeine Citrate Injection and says it is indicated for the treatment of apnoea of prematurity.", "summary_technical": "Product, medicine. openFDA Drugs@FDA lists NDA020793 (sponsor HIKMA), brand CAFCIT, ORIG-1 approved 1999-09-21, Type 2 new active ingredient. The openFDA label for the same application is branded Caffeine Citrate (Hikma Pharmaceuticals USA Inc.), version 12, effective 2024-04-08. The trial of caffeine against placebo that was read for this atlas used caffeine citrate injection, and its sources do not use the Cafcit brand name, so the trial is linked to the substance and not to this product.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-15", "next_review_due": null, "identifiers": [], "navigation": { "maternal": { "life-stage": [ "newborn" ], "care-area": [ "preterm-and-sick-newborn" ] } }, "payload": { "subtype": "medicine", "model_or_formulation": "Caffeine citrate: intravenous solution (Prescription) and oral solution (Discontinued) listed under CAFCIT in Drugs@FDA; the current label read is the injection label.", "version": "openFDA label version 12, effective 2024-04-08", "intended_use_snapshots": [ "maternal:openfda-label-nda020793-2026-10-15", "maternal:openfda-drugsfda-nda020793-2026-10-15" ] }, "content_digest": "a3571267f8bbd8a1ca9e0254d186509c75854ce28785d5da1bd24c9fea2eca92", "review": { "content_digest": "a3571267f8bbd8a1ca9e0254d186509c75854ce28785d5da1bd24c9fea2eca92", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "fc5a600ec7387e71", "id": "maternal:claim-fda-nda020793-cafcit", "owner": "maternal", "subject_entity_id": "maternal:cafcit", "category": "regulatory", "statement": "Drugs@FDA data in openFDA list NDA020793 under the brand name CAFCIT (sponsor HIKMA) with an original submission approved on 1999-09-21, classified Type 2, new active ingredient. Two products are listed: an intravenous solution with marketing status Prescription and an oral solution with marketing status Discontinued. The current US label in openFDA (version 12, effective 2024-04-08, Hikma Pharmaceuticals USA Inc.) is titled Caffeine Citrate Injection, not Cafcit, and says it is indicated for the treatment of apnea of prematurity.", "context": { "id": "maternal:ctx-fda-nda020793-us", "label": "Infants with apnoea of prematurity, US label for caffeine citrate injection (NDA020793)", "recipient": "newborn", "population": "Patients with apnoea of prematurity, for treatment, as the US label words the indication. The label's indication text gives no gestational age or weight limit.", "care_setting": "Not stated in the source", "geography": "United States (FDA-approved labelling)", "life_stage_note": "Infants with apnoea of prematurity", "life_stage_terms": { "maternal": [ "newborn" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory context)", "eligibility": { "inclusion": [ "Infants with apnoea of prematurity (treatment)" ], "exclusion": [] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "The date is that of the original submission's action in openFDA's Drugs@FDA data, not of the current label. The label read is the injection label under the name Caffeine Citrate Injection; the brand name CAFCIT comes from the Drugs@FDA product list, and the label read does not use it. The oral form was not read. Approval means FDA found the product acceptable for the labelled use in the United States; it is not a recommendation for any baby.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "results[0].application_number, sponsor_name, submissions[2] (ORIG 1) and products", "applicability_note": "openFDA drugsfda JSON, CC0.", "snapshot": { "id": "maternal:openfda-drugsfda-nda020793-2026-10-15", "retrieved_at": "2026-10-15T13:50:50Z", "content_hash": "91391284b4d1dab5ee2f5f6571308a84a38558066f670c879bde8283b2265564", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-nda020793", "source_type": "regulator", "title": "FDA application NDA020793, CAFCIT: openFDA Drugs@FDA record", "canonical_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020793", "identifiers": [ { "scheme": "fda-nda", "value": "NDA020793", "normalized_value": "NDA020793", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA drugsfda JSON record fetched on 2026-10-15. It gives the application number, sponsor, products, marketing status and the submission history with status dates written YYYYMMDD.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-drugsfda-NDA020793.json.", "public_text": "quote", "replaced_by": null, "retirement_note": null } }, { "evidence_role": "supports", "locator": "results[0].indications_and_usage[0] and openfda fields, version, effective_time", "applicability_note": "openFDA label record, CC0; label version 12.", "snapshot": { "id": "maternal:openfda-label-nda020793-2026-10-15", "retrieved_at": "2026-10-15T13:51:07Z", "content_hash": "ece7e6af6dadad438af076bb88f07f7c7f54e197ea76a395150a45721f367d0f", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:openfda-label-nda020793", "source_type": "regulator", "title": "Caffeine citrate injection prescribing information for NDA020793: openFDA drug label record", "canonical_url": "https://api.fda.gov/drug/label.json?search=openfda.application_number:%22NDA020793%22", "identifiers": [], "publication_date": null, "publisher": "U.S. Food and Drug Administration (openFDA)", "edition": "The openFDA drug label endpoint, fetched on 2026-10-15. The wording is the dataset's copy of the label as of the date fetched, not the current DailyMed label.", "reuse_basis": "openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/; the licence page was fetched as mn-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2). The raw record is committed at research/snapshots/mn-openfda-label-NDA020793.json. Short quotations only.", "public_text": "quote", "replaced_by": null, "retirement_note": null } } ], "review": { "content_digest": "0ff30423d432148f239c1bd5d11a7a32d04ffc8c06989d5e3fc98c597951f130", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-fda-nda020793-cafcit.json" } ], "decisions": [ { "type": "regulatory_decision", "id": "maternal:regdec-fda-nda020793", "product_id": "maternal:cafcit", "product_version": "CAFCIT as listed in Drugs@FDA for NDA020793 (intravenous solution, Prescription; oral solution, Discontinued), original submission ORIG-1; labelling read is the openFDA injection label version 12, effective 2024-04-08, titled Caffeine Citrate Injection", "indication": "As the current US injection label words it: Caffeine Citrate Injection is indicated for the treatment of apnea of prematurity.", "context_id": "maternal:ctx-fda-nda020793-us", "jurisdictions": [ "US" ], "jurisdiction_note": "United States", "authority_id": "core:fda", "decision_type": "approval", "recall_class": null, "submission_id": "NDA020793", "pathway": "nda", "product_code": null, "device_class": null, "decision_date": "1999-09-21", "valid_to": null, "claim_id": "maternal:claim-fda-nda020793-cafcit" } ], "milestones": [], "relationships": { "outgoing": [ { "predicate": "contains", "label": "Active ingredient (generic name on the label)", "clinical_claim_not_fact": false, "family": "sourced", "other_entity_id": "maternal:caffeine-citrate", "other_entity_in_atlas": true, "claim_id": null, "evidence": { "snapshot_id": "maternal:openfda-label-nda020793-2026-10-15", "locator": "results[0].openfda.generic_name[0]" }, "primary": false, "role": "active", "valid_from": null, "valid_to": null }, { "predicate": "part_of", "label": "Filed under this front", "clinical_claim_not_fact": false, "family": "navigation", "other_entity_id": "maternal:front-medicines-and-vaccines", "other_entity_in_atlas": true, "claim_id": null, "evidence": null, "primary": true, "role": null, "valid_from": null, "valid_to": null } ], "incoming": [] }, "page_path": "products/cafcit/", "context_path": "api/v1/context/maternal--cafcit.md" }