Prescription drug · ANDA
Gabapentin NDC 85534-0009
Gabapentin 600 mg/1 · Tablet · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0009-0 | 85534000900 | 30 TABLET in 1 BOTTLE (85534-0009-0)Marketed from Jul 2, 2026 | |
| 85534-0009-1 | 85534000901 | 60 TABLET in 1 BOTTLE (85534-0009-1)Marketed from Jul 2, 2026 | |
| 85534-0009-2 | 85534000902 | 90 TABLET in 1 BOTTLE (85534-0009-2)Marketed from Jul 2, 2026 | |
| 85534-0009-3 | 85534000903 | 120 TABLET in 1 BOTTLE (85534-0009-3)Marketed from Jul 2, 2026 |
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 — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205101
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 85534-0009_559f2fb7-7b06-ee1a-e063-6394a90a580eSPL ID 559f2fb7-7b06-ee1a-e063-6394a90a580eSPL set ID f6ff265b-569b-4f5c-8fdb-00b7ad4aac7cRxCUI 310433, 310434UNII 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
N485534000900followed by a unit qualifier and the quantityPackage 85534-0009-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.