Prescription drug · ANDA
Galantamine NDC 71335-2766
Galantamine hydrobromide 4 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2766-1 | 71335276601 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2766-1)Marketed from Oct 3, 2025 | |
| 71335-2766-2 | 71335276602 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2766-2)Marketed from Oct 3, 2025 |
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)
- Galantamine
- Generic name (nonproprietary)
- galantamine
- Active ingredients
- Galantamine hydrobromide — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090957
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2766_0ff532b0-a51d-4321-9926-f41ab26be5eeSPL ID 0ff532b0-a51d-4321-9926-f41ab26be5eeSPL set ID 261889d3-41c8-4655-98f7-41317778e7a1RxCUI 310436UNII 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
N471335276601followed by a unit qualifier and the quantityPackage 71335-2766-01. 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)
Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine tablets are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090957
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 | American Health Packaging | 68084-729 |
| Galantamine | Galantamine hydrobromide 12 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-460 |
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-458 |
| Galantamine | Galantamine hydrobromide 8 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-459 |
| Galantamine | Galantamine hydrobromide 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2566 |
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-049 |
| Galantamine | Galantamine hydrobromide 8 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-050 |
| Galantamine | Galantamine hydrobromide 12 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-051 |