Prescription drug · ANDA
Gabapentin NDC 71610-146
Gabapentin 300 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-146-30 | 71610014630 | 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-30)Marketed from Sep 10, 2018 | |
| 71610-146-53 | 71610014653 | 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-53)Marketed from Sep 10, 2018 | |
| 71610-146-60 | 71610014660 | 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-60)Marketed from Sep 10, 2018 | |
| 71610-146-70 | 71610014670 | 120 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-70)Marketed from Sep 10, 2018 | |
| 71610-146-80 | 71610014680 | 180 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-80)Marketed from Sep 10, 2018 | |
| 71610-146-92 | 71610014692 | 270 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-92)Marketed from Sep 10, 2018 | |
| 71610-146-98 | 71610014698 | 540 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-98)Marketed from Sep 10, 2018 |
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
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-146_97600ad8-cdf2-4664-83c1-e1deecb26772SPL ID 97600ad8-cdf2-4664-83c1-e1deecb26772SPL set ID 1b73e9db-eddb-49ba-9778-01d39ece4d16RxCUI 310431UNII 6CW7F3G59X
- Pharmacologic class
- Anti-epileptic Agent
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
N471610014630followed by a unit qualifier and the quantityPackage 71610-0146-30. 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 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 71610-146
- What is NDC 71610-146?
- 71610-146 is the product NDC for Gabapentin, Gabapentin 300 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 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 | NuCare Pharmaceuticals,Inc. | 68071-2600 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8712 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7838 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Proficient Rx LP | 71205-532 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7848 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1257 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-949 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Coupler LLC | 67046-1284 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Proficient Rx LP | 71205-808 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-950 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-421 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-178 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2970 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-051 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8489 |
| Relgaabigabapentin | Gabapentin 300 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-233 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Direct_Rx | 72189-392 |
| Relgaabigabapentin | Gabapentin 200 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-231 |
| Relgaabigabapentin | Gabapentin 400 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-234 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Medsource Pharmaceuticals | 45865-194 |
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