Prescription drug · ANDA
Gabapentin NDC 63187-010
Gabapentin 800 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-010-30 | 63187001030 | 30 TABLET in 1 BOTTLE (63187-010-30)Marketed from Dec 1, 2016 | |
| 63187-010-60 | 63187001060 | 60 TABLET in 1 BOTTLE (63187-010-60)Marketed from Apr 1, 2014 | |
| 63187-010-90 | 63187001090 | 90 TABLET in 1 BOTTLE (63187-010-90)Marketed from Apr 1, 2014 |
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 — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077662
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 63187-010_34b3a9d3-242c-449b-ba6a-ebb2ecf4f37bSPL ID 34b3a9d3-242c-449b-ba6a-ebb2ecf4f37bSPL set ID c78f528f-9192-4037-bfb9-ff5718ed26c5RxCUI 310433, 310434UNII 6CW7F3G59X
- Pharmacologic class
- Anti-epileptic Agent
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
N463187001030followed by a unit qualifier and the quantityPackage 63187-0010-30. 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)
INDICATIONS AND USAGE Postherpetic Neuralgia Gabapentin tablets USP are indicated for the management of postherpetic neuralgia in adults. Epilepsy Gabapentin tablets USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077662
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 600 mg/1 | TabletOral | BluePoint Laboratories | 68001-411 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | BluePoint Laboratories | 68001-412 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0254 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3063 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-036 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-127 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-126 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-2126 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7307 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-2127 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7308 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Proficient Rx LP | 63187-057 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-959 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Coupler LLC | 67046-1086 |