Prescription drug · ANDA
Gabapentin NDC 55154-8189
Gabapentin 600 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-8189-0 | 55154818900 | 10 BLISTER PACK in 1 BAG (55154-8189-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 23, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLC
- 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 55154-8189_106f02cb-f056-4f14-a23b-8fe667d75f82SPL ID 106f02cb-f056-4f14-a23b-8fe667d75f82SPL set ID eeb19a5a-b31d-4df8-9546-0b2b5eb5db07RxCUI 310433, 310434UNII 6CW7F3G59XUPC 0055154819305
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
N455154818900followed by a unit qualifier and the quantityPackage 55154-8189-00. 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: • 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 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)
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 | 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 600 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-127 |
| 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 |