Prescription drug · ANDA
Gabapentin NDC 76420-617
Gabapentin 300 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-617-10 | 76420061710 | 100 CAPSULE in 1 BOTTLE (76420-617-10)Marketed from Sep 30, 2023 | |
| 76420-617-12 | 76420061712 | 120 CAPSULE in 1 BOTTLE (76420-617-12)Marketed from Sep 30, 2023 | |
| 76420-617-24 | 76420061724 | 240 CAPSULE in 1 BOTTLE (76420-617-24)Marketed from Sep 30, 2023 | |
| 76420-617-30 | 76420061730 | 30 CAPSULE in 1 BOTTLE (76420-617-30)Marketed from Sep 30, 2023 | |
| 76420-617-60 | 76420061760 | 60 CAPSULE in 1 BOTTLE (76420-617-60)Marketed from Sep 30, 2023 | |
| 76420-617-90 | 76420061790 | 90 CAPSULE in 1 BOTTLE (76420-617-90)Marketed from Sep 30, 2023 |
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 — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075360
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 76420-617_068d23f0-3994-f3d5-e063-6394a90ae9a4SPL ID 068d23f0-3994-f3d5-e063-6394a90ae9a4SPL set ID 5fb79774-c2d4-47ba-9a16-eb367d0fdcffRxCUI 310431UNII 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
N476420061710followed by a unit qualifier and the quantityPackage 76420-0617-10. 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 is 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 075360
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 | Bryant Ranch Prepack | 71335-1997 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0150 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2004 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Proficient Rx LP | 71205-619 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-661 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc | 70010-928 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc | 70010-926 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc | 70010-927 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-926 |