Prescription drug · ANDA
Gabapentin NDC 64380-867
Gabapentin 100 mg/1 · Capsule · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-867-06 | 64380086706 | 100 CAPSULE in 1 BOTTLE (64380-867-06)Marketed from Oct 17, 2018 | |
| 64380-867-07 | 64380086707 | 500 CAPSULE in 1 BOTTLE (64380-867-07)Marketed from Oct 17, 2018 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211314
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 64380-867_dcbeb06d-b93e-41c0-91e6-152e2ea6c32dSPL ID dcbeb06d-b93e-41c0-91e6-152e2ea6c32dSPL set ID 43b67ae3-ac6f-48f5-8788-9ead08376864RxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0364380867067, 0364380868064, 0364380869061
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
N464380086706followed by a unit qualifier and the quantityPackage 64380-0867-06. 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 211314
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 300 mg/1 | CapsuleOral | Coupler LLC | 67046-1429 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3109 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-868 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-866 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-867 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-869 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-868 |