Prescription drug · ANDA
Gabapentin NDC 55289-959
Gabapentin 600 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-959-30 | 55289095930 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-959-30)Marketed from Jan 27, 2020 | |
| 55289-959-60 | 55289095960 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-959-60)Marketed from Oct 10, 2011 | |
| 55289-959-90 | 55289095990 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-959-90)Marketed from Oct 10, 2011 | |
| 55289-959-98 | 55289095998 | 120 TABLET in 1 BOTTLE, PLASTIC (55289-959-98)Marketed from Oct 10, 2011 |
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
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077662
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 55289-959_3892af8e-2138-00ac-e063-6394a90a516fSPL ID 3892af8e-2138-00ac-e063-6394a90a516fSPL set ID 7c3b232a-3e9f-4249-9e5a-295482ee288aRxCUI 310433UNII 6CW7F3G59XUPC 0355289959908
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
N455289095930followed by a unit qualifier and the quantityPackage 55289-0959-30. 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)
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 077662
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 | BluePoint Laboratories | 68001-411 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | BluePoint Laboratories | 68001-412 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0254 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3063 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-036 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-127 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-126 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Proficient Rx LP | 63187-010 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-2126 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7307 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-2127 |
| Gabapentin | Gabapentin 800 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7308 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Proficient Rx LP | 63187-057 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Coupler LLC | 67046-1086 |