Prescription drug · ANDA
Gabapentin NDC 61919-640
Gabapentin 300 mg/1 · Capsule · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-640-30 | 61919064030 | 30 CAPSULE in 1 BOTTLE (61919-640-30)Marketed from Apr 9, 2019 |
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
- DIRECT RX
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090007
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 61919-640_47e158f3-f67b-74b2-e063-6394a90ac498SPL ID 47e158f3-f67b-74b2-e063-6394a90ac498SPL set ID 29a70e2d-d3fd-4e32-95dd-7ee721d87388RxCUI 310431UNII 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
N461919064030followed by a unit qualifier and the quantityPackage 61919-0640-30. 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)
INDICATIONS & USAGE SECTION Postherpetic Neuralgia Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090007
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 | Bi-Coastal Pharma International LLC | 42582-115 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bi-Coastal Pharma International LLC | 42582-114 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bi-Coastal Pharma International LLC | 42582-116 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7024 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | DIRECT RX | 72189-109 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | DIRECT RX | 72189-113 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0993 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-088 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1490 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-103 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-104 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-105 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4784 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-123 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0079 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1991 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2005 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-605 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-606 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-607 |
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