Prescription drug · ANDA
gabapentin NDC 16571-867
Gabapentin 100 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-867-01 | 16571086701 | 100 CAPSULE in 1 BOTTLE (16571-867-01)Marketed from Aug 1, 2022 | |
| 16571-867-03 | 16571086703 | 30 CAPSULE in 1 BOTTLE (16571-867-03)Marketed from Aug 1, 2022 | |
| 16571-867-10 | 16571086710 | 1000 CAPSULE in 1 BOTTLE (16571-867-10)Marketed from Aug 1, 2022 | |
| 16571-867-50 | 16571086750 | 500 CAPSULE in 1 BOTTLE (16571-867-50)Marketed from Aug 1, 2022 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207099
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 16571-867_2e493243-47c0-460e-bea9-4ed0261adf90SPL ID 2e493243-47c0-460e-bea9-4ed0261adf90SPL set ID 969cccfc-e56a-49da-9d36-47c0c3fad7f8RxCUI 310430, 310431, 310432UNII 6CW7F3G59X
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
N416571086701followed by a unit qualifier and the quantityPackage 16571-0867-01. 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 Capsules 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 capsules 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 207099
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 300 mg/1 | CapsuleOral | Direct_Rx | 72189-610 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-868 |
| gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-869 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-674 |
| gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4706 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-511 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-509 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Epic Pharma, LLC | 42806-510 |
| gabapentin | Gabapentin 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4482 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Proficient Rx LP | 82804-206 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4763 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-073 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Direct_Rx | 72189-524 |
| gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Coupler LLC | 67046-1591 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-5317 |
| gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Proficient Rx LP | 82804-294 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Coupler LLC | 67046-1644 |