Prescription drug · ANDA
Gabapentin NDC 71205-160
Gabapentin 800 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-160-30 | 71205016030 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-160-30)Marketed from Nov 1, 2018 | |
| 71205-160-60 | 71205016060 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-160-60)Marketed from Nov 1, 2018 | |
| 71205-160-90 | 71205016090 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-160-90)Marketed from Nov 1, 2018 |
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, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203244
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71205-160_982c815d-046b-47a5-abf7-f8a0c836543eSPL ID 982c815d-046b-47a5-abf7-f8a0c836543eSPL set ID c09c66fd-cb31-41dd-b00b-acc58bd809f7RxCUI 310434UNII 6CW7F3G59X
- Pharmacologic class
- Anti-epileptic Agent
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
N471205016030followed by a unit qualifier and the quantityPackage 71205-0160-30. 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 203244
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, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-426 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2141 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2142 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2098 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-044 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1007 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1026 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-727 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-728 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1041 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-158 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1132 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-457 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1601 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-066 |