Prescription drug · ANDA
Gabapentin NDC 76420-235
Gabapentin 600 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-235-12 | 76420023512 | 120 TABLET in 1 BOTTLE (76420-235-12)Marketed from Jul 7, 2022 | |
| 76420-235-24 | 76420023524 | 240 TABLET in 1 BOTTLE (76420-235-24)Marketed from Jul 7, 2022 | |
| 76420-235-30 | 76420023530 | 30 TABLET in 1 BOTTLE (76420-235-30)Marketed from Jul 7, 2022 | |
| 76420-235-60 | 76420023560 | 60 TABLET in 1 BOTTLE (76420-235-60)Marketed from Jul 7, 2022 | |
| 76420-235-90 | 76420023590 | 90 TABLET in 1 BOTTLE (76420-235-90)Marketed from Jul 7, 2022 |
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 — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205101
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 76420-235_e347fcb2-dba9-193d-e053-2995a90a4784SPL ID e347fcb2-dba9-193d-e053-2995a90a4784SPL set ID c18d9d06-f796-4eb7-8fd5-1de4ebb95439RxCUI 310433UNII 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
N476420023512followed by a unit qualifier and the quantityPackage 76420-0235-12. 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 is 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 76420-235
- What is NDC 76420-235?
- 76420-235 is the product NDC for Gabapentin, Gabapentin 600 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 5 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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?
- 558 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 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 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4742 | 70518-4742-00 |
| 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 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Coupler LLC | 67046-1086 | 67046-1086-03 |
Other NDCs under ANDA 205101
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 | ScieGen Pharmaceuticals, Inc. | 50228-177 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-178 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-517 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-743 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8489 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8490 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8491 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8492 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Coupler LLC | 67046-1536 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2206 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2214 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7757 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7774 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Proficient Rx LP | 71205-514 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Proficient Rx LP | 71205-533 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Proficient Rx LP | 71205-774 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Proficient Rx LP | 71205-931 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Proficient Rx LP | 71205-932 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-737 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-767 |
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