Prescription drug · ANDA
Caffeine Citrate NDC 42571-244
Caffeine citrate 60 mg/3mL · Injection, Solution · Intramuscular, Intravenous · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-244-98 | 4257102449842571024498 | 10 CARTON in 1 BOX (42571-244-98) / 1 VIAL, GLASS in 1 CARTON (42571-244-69) / 3 mL in 1 VIAL, GLASSMarketed from Dec 30, 2017 |
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
- Generic name (nonproprietary)
- caffeine citrate
- Active ingredients
- Caffeine citrate — 60 mg/3mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207400
- Marketing start
- Listing expires
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 42571-244_57f6d157-d242-b344-e063-6294a90a6b8cSPL ID 57f6d157-d242-b344-e063-6294a90a6b8cSPL set ID 279a43b8-9ff5-4792-ac19-441f3fa49269RxCUI 849931UNII U26EO4675QUPC 0342571244699, 0342571244989
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N442571024498followed by a unit qualifier and the quantityPackage 42571-0244-98. 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 is indicated for the treatment of apnea of prematurity.
Excerpt only. Read the full label for complete information.
About NDC 42571-244
- What is NDC 42571-244?
- 42571-244 is the product NDC for Caffeine Citrate, Caffeine citrate 60 mg/3mL injection, solution, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Caffeine Citrate.
- What is the active ingredient?
- Caffeine citrate.
- Who is the labeler?
- Micro Labs Limited, NDC labeler code 42571. 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?
- 12 other product NDCs are listed under this name. See all Caffeine Citrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Caffeine Citrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Caffeine Citrate | Caffeine citrate 20 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0641-6267 | 00641-6267-10 |
| Caffeine Citrate | Caffeine citrate 20 mg/mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 47335-290 | 47335-0290-44 |
| Caffeine Citrate | Caffeine citrate 60 mg/3mL | SolutionOral | Micro Labs Limited | 42571-346 | 42571-0346-6942571-0346-96 |
| Caffeine Citrate | Caffeine citrate 60 mg/3mL | InjectionIntravenous | Armas Pharmaceuticals Inc. | 72485-104 | 72485-0104-0172485-0104-10 |
| Caffeine Citrate | Caffeine citrate 20 mg/mL | Injection, SolutionIntravenous | Eugia US LLC | 55150-187 | 55150-0187-03 |
| caffeine citrate | Caffeine citrate 20 mg/mL | InjectionIntravenous | Exela Pharma Sciences, LLC | 51754-0500 | 51754-0500-01 |
| Caffeine Citrate | Caffeine citrate 20 mg/mL | InjectionIntravenous | Sun Pharmaceutical Industries, Inc. | 47335-289 | 47335-0289-27 |
| caffeine citrate | Caffeine citrate 20 mg/mL | SolutionIntravenous | Sagent Pharmaceuticals | 25021-601 | 25021-0601-03 |
| caffeine citrate | Caffeine citrate 20 mg/mL | SolutionOral | Sagent Pharmaceuticals | 25021-602 | 25021-0602-03 |
| Caffeine Citrate | Caffeine citrate 20 mg/mL | SolutionOral | Fresenius Kabi USA, LLC | 63323-406 | 63323-0406-03 |
Other NDCs under ANDA 207400
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 | InjectionIntravenous | Armas Pharmaceuticals Inc. | 72485-104 |