Prescription drug · ANDA
Galantamine NDC 51407-907
Galantamine hydrobromide 8 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-907-60 | 51407090760 | 60 TABLET, FILM COATED in 1 BOTTLE (51407-907-60)Marketed from Apr 15, 2024 |
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)
- Galantamine
- Generic name (nonproprietary)
- galantamine
- Active ingredients
- Galantamine hydrobromide — 8 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077604
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 51407-907_547b40f4-a2d2-d9ab-e063-6294a90a8f81SPL ID 547b40f4-a2d2-d9ab-e063-6294a90a8f81SPL set ID 18fd8860-d9ab-1b17-e063-6294a90aad9aRxCUI 310436, 310437, 579148UNII MJ4PTD2VVW
- Pharmacologic class
- Cholinesterase Inhibitor
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
N451407090760followed by a unit qualifier and the quantityPackage 51407-0907-60. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 077604
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 |
|---|---|---|---|---|
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-906 |
| Galantamine | Galantamine hydrobromide 12 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-908 |
| Galantamine | Galantamine hydrobromide 8 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-723 |
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-722 |
| Galantamine | Galantamine hydrobromide 12 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-724 |
| Galantamine | Galantamine hydrobromide 12 mg/1 | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-006 |
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-004 |
| Galantamine | Galantamine hydrobromide 8 mg/1 | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-005 |