Prescription drug · ANDA
gabapentin NDC 68382-355
Gabapentin 450 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-355-01 | 68382035501 | 100 TABLET in 1 BOTTLE (68382-355-01)Marketed from Sep 18, 2025 | |
| 68382-355-14 | 68382035514 | 60 TABLET in 1 BOTTLE (68382-355-14)Marketed from Sep 18, 2025 |
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 — 450 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203934
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68382-355_898c1710-d86c-4fbe-9a53-34661fcdb63aSPL ID 898c1710-d86c-4fbe-9a53-34661fcdb63aSPL set ID 3cfd04ab-e421-441f-a10e-e4dd1412974dRxCUI 1806380, 1806382, 2634743, 2634747, 2634751UNII 6CW7F3G59XUPC 0368382607164
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
N468382035501followed by a unit qualifier and the quantityPackage 68382-0355-01. 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 tablet is indicated for the management of postherpetic neuralgia. Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Gabapentin tablet is indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration (see Warnings and Precautions).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203934
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 750 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1917 |
| gabapentin | Gabapentin 900 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1918 |
| gabapentin | Gabapentin 900 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-357 |
| gabapentin | Gabapentin 750 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-356 |
| gabapentin | Gabapentin 450 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1916 |
| gabapentin | Gabapentin 600 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-607 |
| gabapentin | Gabapentin 300 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-608 |
| gabapentin | Gabapentin 600 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1862 |
| gabapentin | Gabapentin 300 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1861 |