Prescription drug · ANDA
caffeine citrate NDC 51754-0501
Caffeine citrate 20 mg/mL · Solution · Oral · Exela Pharma Sciences, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51754-0501-2 | 51754050102 | 5 VIAL in 1 CARTON (51754-0501-2) / 3 mL in 1 VIALMarketed from Aug 31, 2019 | |
| 51754-0501-3 | 51754050103 | 10 VIAL in 1 CARTON (51754-0501-3) / 3 mL in 1 VIALMarketed from Mar 30, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- caffeine citrate
- Generic name (nonproprietary)
- caffeine citrate
- Active ingredients
- Caffeine citrate — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Exela Pharma Sciences, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077304
- Marketing start
- Listing expires
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 51754-0501_6717d816-ee3c-4633-ba00-98e539734243SPL ID 6717d816-ee3c-4633-ba00-98e539734243SPL set ID 5d05ebf4-fd27-3bd1-5634-b41e33abc41fRxCUI 849928UNII U26EO4675Q
- Pharmacologic class
- Central Nervous System Stimulant; Methylxanthine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451754050102followed by a unit qualifier and the quantityPackage 51754-0501-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
Excerpt only. Read the full label for complete information.