Prescription drug · ANDA
Gabapentin NDC 64380-731
Gabapentin 400 mg/1 · Capsule · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-731-01 | 64380073101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (64380-731-01)Marketed from Jan 8, 2025 | |
| 64380-731-02 | 64380073102 | 500 CAPSULE in 1 BOTTLE, PLASTIC (64380-731-02)Marketed from Jan 8, 2025 | |
| 64380-731-03 | 64380073103 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (64380-731-03)Marketed from Apr 4, 2026 |
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 — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206943
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 64380-731_4dcf85f4-ed27-4fba-a2e3-95a3b8a89b86SPL ID 4dcf85f4-ed27-4fba-a2e3-95a3b8a89b86SPL set ID 798575b9-ddfa-4915-9574-626abbaf025fRxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0364380753018, 0364380731016, 0364380754015
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
N464380073101followed by a unit qualifier and the quantityPackage 64380-0731-01. 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)
Gabapentin capsules, USP 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, USP 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 206943
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 | NuCare Pharmaceuticals,Inc. | 68071-2876 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4411 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4978 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2139 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2138 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2140 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1375 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-317 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Direct_Rx | 72189-419 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Medsource Pharmaceuticals | 45865-216 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4740 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4742 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4746 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8194 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8199 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-753 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-754 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | ADVANCED RX OF TENNESSEE, LLC | 80425-0031 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1348 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | St Mary's Medical Park Pharmacy | 60760-814 |
Showing 20 of 29.