Prescription drug · ANDA
Gabapentin NDC 76282-321
Gabapentin 100 mg/1 · Capsule · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-321-01 | 76282032101 | 100 CAPSULE in 1 BOTTLE (76282-321-01)Marketed from Apr 26, 2010 | |
| 76282-321-05 | 76282032105 | 500 CAPSULE in 1 BOTTLE (76282-321-05)Marketed from Apr 26, 2010 | |
| 76282-321-18 | 76282032118 | 180 CAPSULE in 1 BOTTLE (76282-321-18)Marketed from Mar 20, 2013 | |
| 76282-321-27 | 76282032127 | 270 CAPSULE in 1 BOTTLE (76282-321-27)Marketed from Mar 20, 2013 | |
| 76282-321-90 | 76282032190 | 90 CAPSULE in 1 BOTTLE (76282-321-90)Marketed from Mar 20, 2013 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals, Inc.
- 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 76282-321_5e0a57d7-9068-43d3-be26-96f646720fdeSPL ID 5e0a57d7-9068-43d3-be26-96f646720fdeSPL set ID 41d1ead3-046e-4abf-ae0a-cb126a1f5848RxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0376282323909, 0376282627182, 0376282323053, 0376282321189, 0376282627304, 0376282627908, 0376282627601, 0376282323275, 0376282321271, 0376282321059, 0376282321905, 0376282323015, 0376282321011, 0376282627274, 0376282627014
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
N476282032101followed by a unit qualifier and the quantityPackage 76282-0321-01. 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)
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 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 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-185 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0073 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-943 |