Prescription drug · ANDA
Gabapentin NDC 68382-205
Gabapentin 800 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-205-01 | 68382020501 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-205-01)Marketed from Oct 16, 2012 | |
| 68382-205-05 | 68382020505 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-205-05)Marketed from Oct 16, 2012 | |
| 68382-205-10 | 68382020510 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-205-10)Marketed from Oct 16, 2012 | |
| 68382-205-77 | 68382020577 | 100 BLISTER PACK in 1 CARTON (68382-205-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-205-30)Marketed from Oct 16, 2012 |
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 078926
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68382-205_e85a763f-472b-492b-bf25-a30251b9b50bSPL ID e85a763f-472b-492b-bf25-a30251b9b50bSPL set ID 310ce005-5a24-489a-b23c-d42ab6a3bfedRxCUI 310433, 310434UNII 6CW7F3G59XUPC 0368382204011, 0368382205018
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
N468382020501followed by a unit qualifier and the quantityPackage 68382-0205-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | Cardinal Health 107, LLC | 55154-8189 |
| 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 |