Prescription drug · ANDA
Gabapentin NDC 42192-608
Gabapentin 250 mg/5mL · Solution · Oral · Acella Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42192-608-05 | 4219206080542192060805 | 5 mL in 1 CUP, UNIT-DOSE (42192-608-05)Marketed from Aug 16, 2019 | |
| 42192-608-06 | 4219206080642192060806 | 6 mL in 1 CUP, UNIT-DOSE (42192-608-06)Marketed from Aug 16, 2019 | |
| 42192-608-16 | 4219206081642192060816 | 470 mL in 1 BOTTLE (42192-608-16)Marketed from Oct 1, 2012 | |
| 42192-608-40 | 4219206084042192060840 | 40 CUP, UNIT-DOSE in 1 BOX (42192-608-40) / 6 mL in 1 CUP, UNIT-DOSEMarketed from Aug 16, 2019 | |
| 42192-608-45 | 4219206084542192060845 | 40 CUP, UNIT-DOSE in 1 BOX (42192-608-45) / 5 mL in 1 CUP, UNIT-DOSEMarketed from May 5, 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 — 250 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Acella Pharmaceuticals, LLCNDC labeler code 42192
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076403
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 42192-608_42b42328-c02f-5413-e063-6394a90ace67SPL ID 42b42328-c02f-5413-e063-6394a90ace67SPL set ID 3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2RxCUI 283523UNII 6CW7F3G59XUPC 0342192608160
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
N442192060805followed by a unit qualifier and the quantityPackage 42192-0608-05. 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 Oral Solution 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 Oral Solution 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 42192-608
- What is NDC 42192-608?
- 42192-608 is the product NDC for Gabapentin, Gabapentin 250 mg/5mL solution, listed with the FDA by Acella Pharmaceuticals, LLC. 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?
- Acella Pharmaceuticals, LLC, NDC labeler code 42192. 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?
- 555 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 | 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 |
| 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 |
| Gabapentin | Gabapentin 600 mg/1 | TabletOral | Coupler LLC | 67046-1086 | 67046-1086-03 |
Other NDCs under ANDA 076403
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 250 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0600 |
| Gabapentin | Gabapentin 250 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-1318 |