Prescription drug · ANDA
Caffeine Citrate Oral Solution (Caffeine citrate) NDC 72485-110
Caffeine citrate 60 mg/3mL · Solution · Oral · Armas Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-110-10 | 7248501101072485011010 | 10 VIAL, SINGLE-DOSE in 1 BOX (72485-110-10) / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 1, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Oral Solution
- Generic name (nonproprietary)
- caffeine citrate
- Active ingredients
- Caffeine citrate — 60 mg/3mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Armas Pharmaceuticals Inc.NDC labeler code 72485
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213202
- Marketing start
- Listing expires
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 72485-110_492b9f6d-ad36-4fd7-a3d5-b6cb4a8f01ccSPL ID 492b9f6d-ad36-4fd7-a3d5-b6cb4a8f01ccSPL set ID 2bd238d4-4657-4341-9c28-1b468b8f3bf8RxCUI 849928UNII U26EO4675QUPC 0372485110100
- 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
N472485011010followed by a unit qualifier and the quantityPackage 72485-0110-10. 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 is 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.
About NDC 72485-110
- What is NDC 72485-110?
- 72485-110 is the product NDC for Caffeine Citrate Oral Solution (caffeine citrate), Caffeine citrate 60 mg/3mL solution, listed with the FDA by Armas Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Caffeine Citrate Oral Solution (Caffeine Citrate).
- What is the active ingredient?
- Caffeine citrate.
- Who is the labeler?
- Armas Pharmaceuticals Inc., NDC labeler code 72485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Caffeine Citrate Oral Solution?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 213202
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Caffeine Citrate | Caffeine citrate 60 mg/3mL | SolutionOral | Micro Labs Limited | 42571-346 |