Prescription drug · ANDA
Gabapentin NDC 50228-181
Gabapentin 400 mg/1 · Capsule · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-181-01 | 50228018101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-01)Marketed from Aug 20, 2018 | |
| 50228-181-05 | 50228018105 | 500 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-05)Marketed from Feb 18, 2016 | |
| 50228-181-30 | 50228018130 | 30 CAPSULE in 1 BOTTLE, PLASTIC (50228-181-30)Marketed from Feb 18, 2016 |
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
- ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
- 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 50228-181_572a8a5c-e362-a22e-e063-6294a90a5eb7SPL ID 572a8a5c-e362-a22e-e063-6294a90a5eb7SPL set ID 16542ee6-0e0e-4d3c-8b32-60ff6ef48846RxCUI 310430, 310431, 310432UNII 6CW7F3G59XUPC 0350228180108, 0350228180054, 0350228181013, 0350228178013, 0350228181051, 0350228179010, 0350228180016, 0350228177016, 0350228179102, 0350228178051, 0350228179058, 0350228177054
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
N450228018101followed by a unit qualifier and the quantityPackage 50228-0181-01. 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 50228-181
- What is NDC 50228-181?
- 50228-181 is the product NDC for Gabapentin, Gabapentin 400 mg/1 capsule, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 3 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?
- ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 300 mg/1 | CapsuleOral | Proficient Rx LP | 71205-532 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | ASCLEMED USA INC. | 87063-699 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0182 |
| 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 | Preferred Pharmaceuticals, Inc. | 68788-7848 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Proficient Rx LP | 71205-808 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-949 |
| 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 | Coupler LLC | 67046-1257 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Coupler LLC | 67046-1284 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-259 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2970 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Direct_Rx | 72189-392 |
| Relgaabigabapentin | Gabapentin 200 mg/1 | CapsuleOral | Method Pharmaceuticals, LLC | 58657-231 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-178 |
| 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 | Preferred Pharmaceuticals Inc. | 68788-8489 |
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