Prescription drug · ANDA
Gabapentin NDC 63187-988
Gabapentin 300 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-988-00 | 63187098800 | 100 CAPSULE in 1 BOTTLE (63187-988-00)Marketed from Mar 1, 2018 | |
| 63187-988-30 | 63187098830 | 30 CAPSULE in 1 BOTTLE (63187-988-30)Marketed from Mar 1, 2018 | |
| 63187-988-60 | 63187098860 | 60 CAPSULE in 1 BOTTLE (63187-988-60)Marketed from Mar 1, 2018 | |
| 63187-988-90 | 63187098890 | 90 CAPSULE in 1 BOTTLE (63187-988-90)Marketed from Mar 1, 2018 |
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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075350
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 63187-988_9d1108db-da27-4c84-9a27-2993343c1694SPL ID 9d1108db-da27-4c84-9a27-2993343c1694SPL set ID f651a143-3f88-49c9-b5c4-c9af55aea76aRxCUI 310431UNII 6CW7F3G59XUPC 0363187988609
- 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
N463187098800followed by a unit qualifier and the quantityPackage 63187-0988-00. 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 capsules 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 075350
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 | Bryant Ranch Prepack | 71335-0351 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-072 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-075 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-081 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 45963-555 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 45963-556 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Proficient Rx LP | 71205-064 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 45963-557 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-014 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-015 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-055 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0032 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3494 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3495 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Teva Pharmaceuticals, Inc. | 0480-3496 |