Prescription drug · ANDA
Gabapentin NDC 69292-640
Gabapentin 100 mg/1 · Capsule · Oral · Amici Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69292-640-01 | 69292064001 | 100 CAPSULE in 1 BOTTLE (69292-640-01)Marketed from May 15, 2026 | |
| 69292-640-10 | 69292064010 | 1000 CAPSULE in 1 BOTTLE (69292-640-10)Marketed from May 15, 2026 | |
| 69292-640-50 | 69292064050 | 500 CAPSULE in 1 BOTTLE (69292-640-50)Marketed from May 15, 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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amici Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219319
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 69292-640_49d67ffb-5d4f-486e-8766-cf56faf70edeSPL ID 49d67ffb-5d4f-486e-8766-cf56faf70edeSPL set ID 1ea83c18-7107-41f4-8305-62725c1c45c8RxCUI 310430, 310431, 310432UNII 6CW7F3G59X
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
N469292064001followed by a unit qualifier and the quantityPackage 69292-0640-01. 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 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 is 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 219319
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 | Amici Pharma, Inc. | 69292-642 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Amici Pharma, Inc. | 69292-641 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | STALLION LABORATORIES PRIVATE LIMITED | 72737-005 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | STALLION LABORATORIES PRIVATE LIMITED | 72737-006 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | STALLION LABORATORIES PRIVATE LIMITED | 72737-007 |
| Gabapentin | Gabapentin 200 mg/1 | CapsuleOral | Pangea Pharmaceuticals, LLC | 81279-126 |