Prescription drug · ANDA
gabapentin NDC 71610-069
Gabapentin 600 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-069-45 | 71610006945 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-069-45)Marketed from Feb 26, 2021 | |
| 71610-069-60 | 71610006960 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-069-60)Marketed from May 15, 2018 | |
| 71610-069-80 | 71610006980 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-069-80)Marketed from May 15, 2018 | |
| 71610-069-92 | 71610006992 | 270 TABLET, FILM COATED in 1 BOTTLE (71610-069-92)Marketed from May 15, 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 — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077525
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71610-069_cef6341b-bae4-4e08-a609-1afef9307f2eSPL ID cef6341b-bae4-4e08-a609-1afef9307f2eSPL set ID 7790d906-af26-4e60-bc6f-e906ec03cc24RxCUI 310433UNII 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
N471610006945followed by a unit qualifier and the quantityPackage 71610-0069-45. 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 077525
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 | Sun Pharmaceutical Industries, Inc. | 62756-204 |
| gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-202 |