Prescription drug · ANDA
Gabapentin NDC 69097-811
Gabapentin 800 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-811-02 | 69097081102 | 30 TABLET in 1 BOTTLE (69097-811-02)Marketed from Jul 22, 2016 | |
| 69097-811-07 | 69097081107 | 100 TABLET in 1 BOTTLE (69097-811-07)Marketed from Jul 22, 2016 | |
| 69097-811-12 | 69097081112 | 500 TABLET in 1 BOTTLE (69097-811-12)Marketed from Jul 22, 2016 |
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
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202764
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 69097-811_69887d93-de9a-4397-a629-a0ce8e62c69aSPL ID 69887d93-de9a-4397-a629-a0ce8e62c69aSPL set ID 7c3ac86f-b8f7-42bf-942a-db854d946e54RxCUI 310433, 310434UNII 6CW7F3G59XUPC 0369097812072, 0369097811075
- 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
N469097081102followed by a unit qualifier and the quantityPackage 69097-0811-02. 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: 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, USP 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 202764
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 | Exelan Pharmaceuticals Inc. | 76282-405 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Cipla USA Inc. | 69097-812 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-406 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Proficient Rx LP | 63187-785 |