Prescription drug · ANDA
Gabapentin NDC 63187-785
Gabapentin 600 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-785-00 | 6318707850063187078500 | 100 TABLET in 1 BOTTLE (63187-785-00)Marketed from Dec 1, 2016 | |
| 63187-785-30 | 6318707853063187078530 | 30 TABLET in 1 BOTTLE (63187-785-30)Marketed from Dec 1, 2016 | |
| 63187-785-60 | 6318707856063187078560 | 60 TABLET in 1 BOTTLE (63187-785-60)Marketed from Dec 1, 2016 | |
| 63187-785-72 | 6318707857263187078572 | 120 TABLET in 1 BOTTLE (63187-785-72)Marketed from Dec 1, 2016 | |
| 63187-785-90 | 6318707859063187078590 | 90 TABLET in 1 BOTTLE (63187-785-90)Marketed from Dec 1, 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 — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202764
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 63187-785_1f31e7f3-c013-4492-90ac-481c23448403SPL ID 1f31e7f3-c013-4492-90ac-481c23448403SPL set ID f6baeb5c-ca9c-4730-aeb8-8f8732e8ca3aRxCUI 310433UNII 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
N463187078500followed by a unit qualifier and the quantityPackage 63187-0785-00. 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: • 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 ) Gabapentin Tablets, USP 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
Excerpt only. Read the full label for complete information.
About NDC 63187-785
- What is NDC 63187-785?
- 63187-785 is the product NDC for Gabapentin, Gabapentin 600 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 5 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?
- Proficient Rx LP, NDC labeler code 63187. 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 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-943 | 60760-0943-3060760-0943-90 |
| gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4763 | 70518-4763-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0581 | 55154-0581-00 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0595 | 80425-0595-0180425-0595-0280425-0595-03+1 more |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4746 | 70518-4746-0070518-4746-0170518-4746-02+1 more |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4742 | 70518-4742-0070518-4742-02 |
| 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 |
Other NDCs under ANDA 202764
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 800 mg/1 | TabletOral | Cipla USA Inc. | 69097-811 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Cipla USA Inc. | 69097-812 |
| Gabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-405 |
| Gabapentin | Gabapentin 800 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-406 |