Prescription drug · ANDA
Gabapentin NDC 16571-226
Gabapentin 600 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-226-01 | 16571022601 | 100 TABLET in 1 BOTTLE (16571-226-01)Marketed from Apr 4, 2024 | |
| 16571-226-50 | 16571022650 | 500 TABLET in 1 BOTTLE (16571-226-50)Marketed from Apr 4, 2024 |
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 — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217995
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 16571-226_e4b713f1-a833-4fc7-8a0f-696077ddc280SPL ID e4b713f1-a833-4fc7-8a0f-696077ddc280SPL set ID 8215da86-d7af-4980-b6d6-4bd46f6bfeafRxCUI 310433UNII 6CW7F3G59XUPC 0316571226016
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
N416571022601followed by a unit qualifier and the quantityPackage 16571-0226-01. 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 Tablets 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 Gabapentin tablets are 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 217995
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 | TabletOral | Bryant Ranch Prepack | 71335-3060 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-117 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-7714 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-7715 |