Prescription drug · ANDA
Galantamine NDC 57237-050
Galantamine hydrobromide 8 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-050-60 | 57237005060 | 60 TABLET, FILM COATED in 1 BOTTLE (57237-050-60)Marketed from Mar 29, 2011 |
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
- Labeler
- Rising Pharma Holdings, Inc.
- 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 57237-050_f59a93d6-9a01-40ad-a9ef-4eaacff23b79SPL ID f59a93d6-9a01-40ad-a9ef-4eaacff23b79SPL set ID a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243RxCUI 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
N457237005060followed by a unit qualifier and the quantityPackage 57237-0050-60. 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
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 12 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-051 |
| Galantamine | Galantamine hydrobromide 4 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2766 |