# Cafcit (caffeine citrate) Product · id `maternal:cafcit` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: CAFCIT Browse, life stage: Newborn Browse, care area: Preterm and sick newborns ## In plain language 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. ## Technical summary 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. ## Claims, with the population each applies to ## Context: 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: Infants with apnoea of prematurity; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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: Infants with apnoea of prematurity; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - 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. - Last checked: 2026-10-15 - Sources: 1. Supports: FDA application NDA020793, CAFCIT: openFDA Drugs@FDA record (Regulator, 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.) Locator: results\[0\].application\_number, sponsor\_name, submissions\[2\] (ORIG 1) and products. Retrieved 2026-10-15T13:50:50Z. Source state: Current. Snapshot hash: 91391284b4d1dab5ee2f5f6571308a84a38558066f670c879bde8283b2265564. How it applies: openFDA drugsfda JSON, CC0. 2. Supports: Caffeine citrate injection prescribing information for NDA020793: openFDA drug label record (Regulator, 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.) Locator: results\[0\].indications\_and\_usage\[0\] and openfda fields, version, effective\_time. Retrieved 2026-10-15T13:51:07Z. Source state: Current. Snapshot hash: ece7e6af6dadad438af076bb88f07f7c7f54e197ea76a395150a45721f367d0f. How it applies: openFDA label record, CC0; label version 12. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-nda020793` - Product: Cafcit (caffeine citrate) (`maternal:cafcit`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 1999-09-21 - 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 - Pathway: NDA - Submission: NDA020793 - Indication: As the current US injection label words it: Caffeine Citrate Injection is indicated for the treatment of apnea of prematurity. - Jurisdictions: United States; note: United States - Applies to: 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: Infants with apnoea of prematurity; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Not applicable (regulatory context) - Basis: claim `maternal:claim-fda-nda020793-cafcit` ## Connected pages - Active ingredient (generic name on the label): Caffeine citrate (`maternal:caffeine-citrate`) - Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`) ## Provenance Content hash: a3571267f8bbd8a1ca9e0254d186509c75854ce28785d5da1bd24c9fea2eca92 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15