Quick answers
- What is Caffeine citrate used for?
- The FDA-approved label (Caffeine Citrate, Hikma Pharmaceuticals USA Inc., April 8, 2024) says: “Caffeine Citrate Injection is indicated for the treatment of apnea of prematurity.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Caffeine citrate have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Caffeine citrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Caffeine citrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Caffeine citrate?
- 8 companies list prescription products of Caffeine citrate in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Armas Pharmaceuticals Inc. and Sagent Pharmaceuticals.
What Caffeine citrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Caffeine Citrate Injection is indicated for the treatment of apnea of prematurity.
— FDA label: Caffeine Citrate, Hikma Pharmaceuticals USA Inc., effective April 8, 2024. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Injection · Injection, solution |
|---|---|
| Route | Intravenous · Oral · Intramuscular |
| Prescription products | 14 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fresenius Kabi USA, LLC3 products
- Armas Pharmaceuticals Inc.2 products
- Sagent Pharmaceuticals2 products
- Micro Labs Limited2 products
- Exela Pharma Sciences, LLC2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Eugia US LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020793 CAFCIT | Hikma | September 21, 1999 | 8, latest March 2, 2020 2020: Labeling · 2014: Manufacturing (CMC) · 2010: Labeling |
Generic approvals (11)
- ANDA077233Exela Pharma Science · September 21, 2006
- ANDA077304Exela Pharma · September 21, 2006
- ANDA077997Fresenius Kabi USA · July 20, 2007
- ANDA078002Fresenius Kabi USA · January 31, 2008
- ANDA090077Sun Pharm · September 30, 2009
- ANDA090357Sun Pharm · September 30, 2009
- ANDA090827Sagent Pharms · August 29, 2012
- ANDA091102Sagent Pharms · August 29, 2012
- ANDA205013Eugia Pharma · September 22, 2015
- ANDA207400Micro Labs · December 14, 2017
- ANDA213202Micro Labs · December 16, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 849928, 849931 |
|---|---|
| SPL set ID of the quoted label | 21489401-f2a7-47d3-897a-4b7efa04dd7a |
| FDA labels (SPL) | 14 |
| FDA applications | NDA020793, 11 ANDA |
| Active ingredients (FDA) | CAFFEINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Caffeine Citrate, Hikma Pharmaceuticals USA Inc., effective April 8, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →