Prescription drug · ANDA
Gabapentin NDC 17856-0600
Gabapentin 250 mg/5mL · Solution · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0600-1 | 17856060001 | 72 CUP, UNIT-DOSE in 1 BOX (17856-0600-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0600-4)Marketed from May 7, 2024 | |
| 17856-0600-2 | 17856060002 | 72 CUP, UNIT-DOSE in 1 BOX (17856-0600-2) / 6 mL in 1 CUP, UNIT-DOSE (17856-0600-5)Marketed from May 7, 2024 | |
| 17856-0600-7 | 17856060007 | 5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0600-7) / 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0600-3) / 2 mL in 1 SYRINGE (17856-0600-6)Marketed from May 7, 2024 | |
| 17856-0600-8 | 17856060008 | 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0600-8) / 2 mL in 1 SYRINGE (17856-0600-9)Marketed from Feb 5, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- ATLANTIC BIOLOGICALS CORP.
- 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 17856-0600_361f9f34-f186-da49-e063-6394a90a3d51SPL ID 361f9f34-f186-da49-e063-6394a90a3d51SPL set ID 5969f1a8-d6d5-4967-add5-4e2492354d7bRxCUI 283523UNII 6CW7F3G59X
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
N417856060001followed by a unit qualifier and the quantityPackage 17856-0600-01. 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 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.
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 | Acella Pharmaceuticals, LLC | 42192-608 |
| Gabapentin | Gabapentin 250 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-1318 |