Prescription drug · ANDA
Gabapentin NDC 65162-101
Gabapentin 100 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-101-03 | 65162010103 | 30 CAPSULE in 1 BOTTLE (65162-101-03)Marketed from Nov 24, 2009 | |
| 65162-101-10 | 65162010110 | 100 CAPSULE in 1 BOTTLE (65162-101-10)Marketed from Nov 24, 2009 | |
| 65162-101-11 | 65162010111 | 1000 CAPSULE in 1 BOTTLE (65162-101-11)Marketed from Nov 24, 2009 | |
| 65162-101-50 | 65162010150 | 500 CAPSULE in 1 BOTTLE (65162-101-50)Marketed from Nov 24, 2009 |
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)
- Gabapentin
- Generic name (nonproprietary)
- gabapentin
- Active ingredients
- Gabapentin — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078428
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 65162-101_385f01e9-5b50-41d8-a2d5-748f5f84c027SPL ID 385f01e9-5b50-41d8-a2d5-748f5f84c027SPL set ID 507bf6d0-e7a2-413d-9848-cd2445a1411dRxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0365162101034, 0365162102031, 0365162103038
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
N465162010103followed by a unit qualifier and the quantityPackage 65162-0101-03. 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)
Gabapentin capsules are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin capsules are indicated for: Postherpetic neuralgia in adults. ( 1 ) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078428
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 |
|---|---|---|---|---|
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0820 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0214 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0220 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-034 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1813 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-101 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-102 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-103 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1102 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1103 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-2101 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7306 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-103 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-102 |