Prescription drug · ANDA
gabapentin NDC 62756-204
Gabapentin 800 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-204-01 | 62756020401 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-204-01)Marketed from Sep 1, 2022 | |
| 62756-204-03 | 62756020403 | 500 TABLET, FILM COATED in 1 BOTTLE (62756-204-03)Marketed from Sep 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 — 800 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 62756-204_ca2658ac-c659-4217-8625-a1043d211cd5SPL ID ca2658ac-c659-4217-8625-a1043d211cd5SPL set ID c9a05f0c-b5f0-422c-9d67-6d0efc921a74UNII 6CW7F3G59XUPC 0362756204010, 0362756202016, 0362756138025, 0362756137028, 0362756139022
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
N462756020401followed by a unit qualifier and the quantityPackage 62756-0204-01. 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 600 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-069 |
| gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-202 |