Prescription drug · ANDA
Gabapentin NDC 67877-428
Gabapentin 600 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-428-01 | 67877042801 | 100 TABLET in 1 BOTTLE (67877-428-01)Marketed from Nov 1, 2015 | |
| 67877-428-05 | 67877042805 | 500 TABLET in 1 BOTTLE (67877-428-05)Marketed from Nov 1, 2015 | |
| 67877-428-10 | 67877042810 | 1000 TABLET in 1 BOTTLE (67877-428-10)Marketed from Nov 1, 2015 | |
| 67877-428-38 | 67877042838 | 100 BLISTER PACK in 1 CARTON (67877-428-38) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 1, 2015 |
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
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206402
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 67877-428_b21e5d1f-cac9-4727-bbe4-48335103aef3SPL ID b21e5d1f-cac9-4727-bbe4-48335103aef3SPL set ID 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9aRxCUI 310433, 310434UNII 6CW7F3G59X
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
N467877042801followed by a unit qualifier and the quantityPackage 67877-0428-01. 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 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.
Other NDCs under ANDA 206402
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 | REMEDYREPACK INC. | 70518-2842 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2037 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Direct_Rx | 72189-619 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2038 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-429 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2912 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2048 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0035 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-5310 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1200 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2281 |