Prescription drug · ANDA
Gabapentin NDC 76282-627
Gabapentin 300 mg/1 · Capsule · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-627-01 | 7628206270176282062701 | 100 CAPSULE in 1 BOTTLE (76282-627-01)Marketed from Sep 13, 2018 | |
| 76282-627-05 | 7628206270576282062705 | 500 CAPSULE in 1 BOTTLE (76282-627-05)Marketed from Sep 13, 2018 | |
| 76282-627-18 | 7628206271876282062718 | 180 CAPSULE in 1 BOTTLE (76282-627-18)Marketed from Sep 13, 2018 | |
| 76282-627-27 | 7628206272776282062727 | 270 CAPSULE in 1 BOTTLE (76282-627-27)Marketed from Sep 13, 2018 | |
| 76282-627-30 | 7628206273076282062730 | 30 CAPSULE in 1 BOTTLE (76282-627-30)Marketed from Sep 13, 2018 | |
| 76282-627-60 | 7628206276076282062760 | 60 CAPSULE in 1 BOTTLE (76282-627-60)Marketed from Sep 13, 2018 | |
| 76282-627-90 | 7628206279076282062790 | 90 CAPSULE in 1 BOTTLE (76282-627-90)Marketed from Sep 13, 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
- Exelan Pharmaceuticals, Inc.NDC labeler code 76282
- 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 76282-627_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
N476282062701followed by a unit qualifier and the quantityPackage 76282-0627-01. 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.
About NDC 76282-627
- What is NDC 76282-627?
- 76282-627 is the product NDC for Gabapentin, Gabapentin 300 mg/1 capsule, listed with the FDA by Exelan Pharmaceuticals, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gabapentin.
- What is the active ingredient?
- Gabapentin.
- Who is the labeler?
- Exelan Pharmaceuticals, Inc., NDC labeler code 76282. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gabapentin?
- 561 other product NDCs are listed under this name. See all Gabapentin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gabapentin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-943 | 60760-0943-3060760-0943-90 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4763 | 70518-4763-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0581 | 55154-0581-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0595 | 80425-0595-0180425-0595-0280425-0595-03+1 more |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4746 | 70518-4746-0070518-4746-0170518-4746-02+1 more |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4742 | 70518-4742-0070518-4742-02 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4740 | 70518-4740-00 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0580 | 55154-0580-00 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1233 | 67046-1233-03 |
| Gabapentin | Gabapentin 200 mg/1 | CapsuleOral | Trifluent Pharma, LLC | 73352-231 | 73352-0231-01 |
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 300 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-943 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-020 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-166 |
| 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 400 mg/1 | CapsuleOral | Proficient Rx LP | 63187-909 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4261 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-815 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cipla USA Inc. | 69097-813 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1454 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1453 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-392 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-321 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Exelan Pharmaceuticals, Inc. | 76282-323 |