Prescription drug · ANDA
Gabapentin NDC 58118-1103
Gabapentin 400 mg/1 · Capsule · Oral · Clinical Solutions Wholesale, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58118-1103-8 | 58118110308 | 30 CAPSULE in 1 BLISTER PACK (58118-1103-8)Marketed from Apr 10, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078428
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 58118-1103_15c4b320-aeb7-6e3b-e063-6294a90a277bSPL ID 15c4b320-aeb7-6e3b-e063-6294a90a277bSPL set ID dbedccfb-0e27-4119-93b9-241c039e045aRxCUI 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
N458118110308followed by a unit qualifier and the quantityPackage 58118-1103-08. 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 078428
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 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0820 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0214 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0220 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-034 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1813 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-101 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-102 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-103 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1102 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-2101 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7306 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-103 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-101 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-102 |