Cafcit (caffeine citrate)

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)

• Regulatory Evidence stage not applicable Certainty not assessed

  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.

  Applies to Newborn

  • 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.
  • Not stated in the source
  • United States (FDA-approved labelling)
  • Infants with apnoea of prematurity
  • Gestational age Not reported
  • Postnatal age Not reported

  Follow-up Not applicable (regulatory context)

  Certainty method

  Not assessed

  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

  Next evidence check due

  Not scheduled

  Sources and citations (2)

  1. Supports FDA application NDA020793, CAFCIT: openFDA Drugs@FDA record

     Regulator · 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. · NDA: NDA020793

     Locator

     results[0].application_number, sponsor_name, submissions[2] (ORIG 1) and products

     How it applies

     openFDA drugsfda JSON, CC0.

     Retrieved

     2026-10-15T13:50:50Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     91391284b4d1dab5ee2f5f6571308a84a38558066f670c879bde8283b2265564

     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.

  2. Supports Caffeine citrate injection prescribing information for NDA020793: openFDA drug label record

     Regulator · 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.

     Locator

     results[0].indications_and_usage[0] and openfda fields, version, effective_time

     How it applies

     openFDA label record, CC0; label version 12.

     Retrieved

     2026-10-15T13:51:07Z

     Source effective date

     Not reported

     Source state

     Current

     Snapshot hash

     ece7e6af6dadad438af076bb88f07f7c7f54e197ea76a395150a45721f367d0f

     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.