Prescription drug · ANDA
gabapentin NDC 62756-139
Gabapentin 400 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-139-01 | 62756013901 | 50 CAPSULE in 1 BOX, UNIT-DOSE (62756-139-01)Marketed from Feb 1, 2022 | |
| 62756-139-03 | 62756013903 | 100 CAPSULE in 1 BOTTLE (62756-139-03)Marketed from Feb 1, 2022 |
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
- Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077242
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 62756-139_ca2658ac-c659-4217-8625-a1043d211cd5SPL ID ca2658ac-c659-4217-8625-a1043d211cd5SPL set ID c9a05f0c-b5f0-422c-9d67-6d0efc921a74UNII 6CW7F3G59XUPC 0362756204010, 0362756202016, 0362756138025, 0362756137028, 0362756139022
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
N462756013901followed by a unit qualifier and the quantityPackage 62756-0139-01. 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.
About NDC 62756-139
- What is NDC 62756-139?
- 62756-139 is the product NDC for gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- gabapentin.
- What is the active ingredient?
- Gabapentin.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for gabapentin?
- 561 other product NDCs are listed under this name. See all gabapentin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other gabapentin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4763 | 70518-4763-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0595 | 80425-0595-0180425-0595-0280425-0595-03+1 more |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0581 | 55154-0581-00 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4746 | 70518-4746-0070518-4746-0170518-4746-02 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4742 | 70518-4742-00 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4740 | 70518-4740-00 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0580 | 55154-0580-00 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1233 | 67046-1233-03 |
| Gabapentin | Gabapentin 200 mg/1 | CapsuleOral | Trifluent Pharma, LLC | 73352-231 | 73352-0231-01 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Coupler LLC | 67046-1086 | 67046-1086-03 |
Other NDCs under ANDA 077242
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 | Sun Pharmaceutical Industries, Inc. | 62756-137 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 62756-138 |