Prescription drug · ANDA
Gabapentin NDC 71610-185
Gabapentin 300 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-185-30 | 71610018530 | 30 CAPSULE in 1 BOTTLE (71610-185-30)Marketed from Nov 2, 2018 | |
| 71610-185-53 | 71610018553 | 60 CAPSULE in 1 BOTTLE (71610-185-53)Marketed from Nov 2, 2018 | |
| 71610-185-60 | 71610018560 | 90 CAPSULE in 1 BOTTLE (71610-185-60)Marketed from Nov 12, 2018 | |
| 71610-185-70 | 71610018570 | 120 CAPSULE in 1 BOTTLE (71610-185-70)Marketed from Nov 2, 2018 | |
| 71610-185-80 | 71610018580 | 180 CAPSULE in 1 BOTTLE (71610-185-80)Marketed from Nov 12, 2018 | |
| 71610-185-92 | 71610018592 | 270 CAPSULE in 1 BOTTLE (71610-185-92)Marketed from Nov 12, 2018 | |
| 71610-185-94 | 71610018594 | 360 CAPSULE in 1 BOTTLE (71610-185-94)Marketed from Nov 12, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090705
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71610-185_e1f89ae6-021d-4fcd-ad58-27f2be19fd6eSPL ID e1f89ae6-021d-4fcd-ad58-27f2be19fd6eSPL set ID a900bafb-8f49-4a01-ba7f-4fb228ec0253RxCUI 310431UNII 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
N471610018530followed by a unit qualifier and the quantityPackage 71610-0185-30. 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)
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 090705
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 | Proficient Rx LP | 63187-909 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-321 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1453 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4261 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-323 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1454 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-813 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-815 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-020 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-392 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-166 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-627 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0073 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-943 |