Prescription drug · ANDA
gabapentin NDC 50228-524
Gabapentin 600 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-524-05 | 50228052405 | 500 TABLET in 1 BOTTLE (50228-524-05)Marketed from Sep 20, 2025 | |
| 50228-524-30 | 50228052430 | 30 TABLET in 1 BOTTLE (50228-524-30)Marketed from Sep 20, 2025 | |
| 50228-524-90 | 50228052490 | 90 TABLET in 1 BOTTLE (50228-524-90)Marketed from Sep 20, 2025 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218491
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 50228-524_3f2e32c6-5993-0189-e063-6294a90a0ff6SPL ID 3f2e32c6-5993-0189-e063-6294a90a0ff6SPL set ID 3f2e3ac5-5233-fd57-e063-6294a90a849eRxCUI 1806380, 1806382UNII 6CW7F3G59XUPC 0350228523905
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
N450228052405followed by a unit qualifier and the quantityPackage 50228-0524-05. 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 tablets (Once-Daily) are indicated for the management of postherpetic neuralgia. Gabapentin tablets (Once-Daily) are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Gabapentin tablets are indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation: Gabapentin tablets (Once-Daily) is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration ( See Warnings and Precautions )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218491
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 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-523 |