Prescription drug · ANDA
Gabapentin NDC 68788-8563
Gabapentin 100 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8563-1 | 68788856301 | 100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-1)Marketed from Jan 10, 2024 | |
| 68788-8563-3 | 68788856303 | 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-3)Marketed from Jan 10, 2024 | |
| 68788-8563-6 | 68788856306 | 60 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-6)Marketed from Jan 10, 2024 | |
| 68788-8563-8 | 68788856308 | 120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-8)Marketed from Jan 10, 2024 | |
| 68788-8563-9 | 68788856309 | 90 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-9)Marketed from Jan 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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204989
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 68788-8563_561b2673-98f8-484f-88a7-0bc7e46314ebSPL ID 561b2673-98f8-484f-88a7-0bc7e46314ebSPL set ID 2625c0ef-5295-41de-9e81-88001a6cbeccRxCUI 310430UNII 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
N468788856301followed by a unit qualifier and the quantityPackage 68788-8563-01. 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 204989
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 | Proficient Rx LP | 71205-638 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Direct_Rx | 72189-392 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2970 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0182 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8489 |
| Relgaabigabapentin | Gabapentin 200 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-231 |
| Relgaabigabapentin | Gabapentin 300 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-233 |
| Relgaabigabapentin | Gabapentin 400 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-234 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-289 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8485 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8484 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8488 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Medsource Pharmaceuticals | 45865-194 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8486 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8487 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-259 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3140 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-741 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7672 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7673 |
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