Prescription drug · ANDA
Gabapentin NDC 80425-0196
Gabapentin 300 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0196-1 | 80425019601 | 30 CAPSULE in 1 BOTTLE (80425-0196-1)Marketed from Oct 26, 2023 | |
| 80425-0196-2 | 80425019602 | 60 CAPSULE in 1 BOTTLE (80425-0196-2)Marketed from Oct 26, 2023 | |
| 80425-0196-3 | 80425019603 | 90 CAPSULE in 1 BOTTLE (80425-0196-3)Marketed from Oct 26, 2023 | |
| 80425-0196-4 | 80425019604 | 120 CAPSULE in 1 BOTTLE (80425-0196-4)Marketed from Mar 30, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075477
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 80425-0196_2a99bd40-3c52-3207-e063-6294a90a4faaSPL ID 2a99bd40-3c52-3207-e063-6294a90a4faaSPL set ID ebf57adf-b066-2959-e053-2a95a90a961cRxCUI 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
N480425019601followed by a unit qualifier and the quantityPackage 80425-0196-01. 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)
1. Indications and Usage 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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075477
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 | Mullan Pharmaceutical Inc. | 83301-0005 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-344 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-343 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-345 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0199 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0286 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Proficient Rx LP | 82804-217 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Mullan Pharmaceutical Inc. | 83301-0004 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Mullan Pharmaceutical Inc. | 83301-0003 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-226 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3527 |