Prescription drug · ANDA
Gabapentin NDC 68094-589
Gabapentin 600 mg/1 · Tablet, Coated · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-589-50 | 68094058950 | 100 TABLET, COATED in 1 BOTTLE (68094-589-50)Marketed from Feb 15, 2024 | |
| 68094-589-60 | 68094058960 | 500 TABLET, COATED in 1 BOTTLE (68094-589-60)Marketed from Feb 15, 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 — 600 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Precision Dose, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207057
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68094-589_471ad25b-0c63-489c-9df3-44ea7fdcd256SPL ID 471ad25b-0c63-489c-9df3-44ea7fdcd256SPL set ID 86c93d8b-6286-44e2-93dd-f1b10a5d83daRxCUI 310433, 310434UNII 6CW7F3G59XUPC 0368094589505
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
N468094058950followed by a unit qualifier and the quantityPackage 68094-0589-50. 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 207057
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 800 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-347 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-346 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, CoatedOral | Mullan Pharmaceutical Inc. | 83301-0002 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Mullan Pharmaceutical Inc. | 83301-0001 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Advanced Rx of Tennessee, LLC | 80425-0201 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, CoatedOral | Advanced Rx of Tennessee, LLC | 80425-0204 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7400 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-203 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-210 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | TAGI Pharma, Inc. | 51224-021 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, CoatedOral | TAGI Pharma, Inc. | 51224-121 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-3523 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7268 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Precision Dose, Inc. | 68094-069 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals, Inc. | 68071-3783 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7269 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1233 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, CoatedOral | Precision Dose, Inc. | 68094-489 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 71335-1287 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | AvPAK | 50268-325 |