Prescription drug · ANDA
Gabapentin NDC 65862-200
Gabapentin 400 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-200-01 | 65862020001 | 100 CAPSULE in 1 BOTTLE (65862-200-01)Marketed from Jan 31, 2008 | |
| 65862-200-05 | 65862020005 | 500 CAPSULE in 1 BOTTLE (65862-200-05)Marketed from Jan 31, 2008 | |
| 65862-200-10 | 65862020010 | 10 BLISTER PACK in 1 CARTON (65862-200-10) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jan 31, 2008 | |
| 65862-200-27 | 65862020027 | 270 CAPSULE in 1 BOTTLE (65862-200-27)Marketed from Apr 29, 2021 | |
| 65862-200-90 | 65862020090 | 90 CAPSULE in 1 BOTTLE (65862-200-90)Marketed from Apr 29, 2021 |
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 — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078787
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 65862-200_7a45ad84-02a4-442d-8401-1a1495d084faSPL ID 7a45ad84-02a4-442d-8401-1a1495d084faSPL set ID 1a619a14-0b63-4cba-80e7-474c9a1c90b9RxCUI 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
N465862020001followed by a unit qualifier and the quantityPackage 65862-0200-01. 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 078787
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 | REMEDYREPACK INC. | 70518-2911 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-663 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Proficient Rx LP | 71205-295 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6718 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-199 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-198 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-373 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1484 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-126 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0949 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2699 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2700 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-663 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-661 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-662 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1072 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-188 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6875 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2748 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0082 |
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