Prescription drug · ANDA
Gabapentin NDC 76420-837
Gabapentin 800 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-837-01 | 76420083701 | 100 TABLET in 1 BOTTLE (76420-837-01)Marketed from Aug 7, 2024 | |
| 76420-837-05 | 76420083705 | 500 TABLET in 1 BOTTLE (76420-837-05)Marketed from Aug 7, 2024 | |
| 76420-837-12 | 76420083712 | 120 TABLET in 1 BOTTLE (76420-837-12)Marketed from Sep 23, 2026 | |
| 76420-837-30 | 76420083730 | 30 TABLET in 1 BOTTLE (76420-837-30)Marketed from Aug 7, 2024 | |
| 76420-837-60 | 76420083760 | 60 TABLET in 1 BOTTLE (76420-837-60)Marketed from Aug 7, 2024 | |
| 76420-837-90 | 76420083790 | 90 TABLET in 1 BOTTLE (76420-837-90)Marketed from Aug 7, 2024 |
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 — 800 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 214957
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 76420-837_5c2a0ef4-73bb-7a80-e063-6294a90afdc5SPL ID 5c2a0ef4-73bb-7a80-e063-6294a90afdc5
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
N476420083701followed by a unit qualifier and the quantityPackage 76420-0837-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 76420-837
- What is NDC 76420-837?
- 76420-837 is the product NDC for Gabapentin, Gabapentin 800 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 6 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 214957
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 | Camber Pharmaceuticals, Inc. | 31722-166 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-167 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-6189 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0166 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-1167 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-837 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-987 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Coupler LLC | 67046-1535 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Coupler LLC | 67046-1667 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3445 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8468 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8476 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8488 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8790 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3057 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3143 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-621 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-630 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Direct_Rx | 72189-394 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Direct_Rx | 72189-471 |
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