Prescription drug · ANDA
Gabapentin NDC 72789-127
Gabapentin 600 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-127-90 | 72789012790 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-90)Marketed from Dec 1, 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, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078926
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 72789-127_4d515374-ab61-d0f9-e063-6294a90ab3f7SPL ID 4d515374-ab61-d0f9-e063-6294a90ab3f7SPL set ID 81774da8-cb1d-4c7d-8550-35396850d5ffRxCUI 310433UNII 6CW7F3G59XUPC 0372789127903
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
N472789012790followed by a unit qualifier and the quantityPackage 72789-0127-90. 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 tablets are 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 ) Gabapentin tablets 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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078926
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 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8189 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-507 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-518 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-705 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-706 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8193 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-611 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-204 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-205 |