Prescription drug · ANDA
Terbinafine Hydrochloride (terbinafine tablets 250 mg) NDC 51407-995
Terbinafine hydrochloride 250 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-995-01 | 51407099501 | 100 TABLET in 1 BOTTLE (51407-995-01)Marketed from Dec 31, 2025 | |
| 51407-995-30 | 51407099530 | 30 TABLET in 1 BOTTLE (51407-995-30)Marketed from Dec 31, 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)
- Terbinafine Hydrochloride
- Generic name (nonproprietary)
- terbinafine tablets 250 mg
- Active ingredients
- Terbinafine hydrochloride — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076390
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 51407-995_507501c8-581c-ba3b-e063-6394a90aa989SPL ID 507501c8-581c-ba3b-e063-6394a90aa989SPL set ID 50750500-6cb0-62dc-e063-6294a90a15bcRxCUI 313222UNII 012C11ZU6G
- Pharmacologic class
- Allylamine Antifungal
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
N451407099501followed by a unit qualifier and the quantityPackage 51407-0995-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 076390
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 |
|---|---|---|---|---|
| Terbinafineterbinafine hydrochloride tablet | Terbinafine hydrochloride 250 mg/1 | TabletOral | Amerisyn LLC | 87564-010 |
| Terbinafine Hydrochloride | Terbinafine hydrochloride 250 mg/1 | TabletOral | Dr.Reddys Laboratories Limited | 55111-250 |
| Terbinafine Hydrochlorideterbinafine tablets 250 mg | Terbinafine hydrochloride 250 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-225 |