Prescription drug · ANDA
Gabapentin NDC 42385-973
Gabapentin 300 mg/1 · Capsule · Oral · Laurus Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42385-973-01 | 42385097301 | 100 CAPSULE in 1 BOTTLE (42385-973-01)Marketed from May 13, 2023 | |
| 42385-973-05 | 42385097305 | 500 CAPSULE in 1 BOTTLE (42385-973-05)Marketed from May 13, 2023 | |
| 42385-973-11 | 42385097311 | 1000 CAPSULE in 1 BOTTLE (42385-973-11)Marketed from May 13, 2023 | |
| 42385-973-30 | 42385097330 | 30 CAPSULE in 1 BOTTLE (42385-973-30)Marketed from May 13, 2023 | |
| 42385-973-72 | 42385097372 | 10 BLISTER PACK in 1 CARTON (42385-973-72) / 10 CAPSULE in 1 BLISTER PACKMarketed from May 13, 2023 | |
| 42385-973-90 | 42385097390 | 90 CAPSULE in 1 BOTTLE (42385-973-90)Marketed from May 13, 2023 |
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 — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Laurus Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217546
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 42385-973_5fd82a02-46ac-4312-a008-fa17e5cd3ffdSPL ID 5fd82a02-46ac-4312-a008-fa17e5cd3ffdSPL set ID 07aa1bcc-df05-44fa-92d4-63894e0e6cd6RxCUI 310430, 310431, 310432, 310433, 310434UNII 6CW7F3G59XUPC 0342385980301
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
N442385097301followed by a unit qualifier and the quantityPackage 42385-0973-01. 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 217546
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 100 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-972 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Laurus Labs Limited | 42385-974 |