Terbinafine
- Product NDC
- 70518-4323
- 11-digit product format
- 705184323
- Labeler code
- 70518
- Product ID
- 70518-4323_316807fa-b484-7ab1-e063-6394a90a7878
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077533
- Marketing category
- ANDA
- Marketing start
- 2025-03-28
- Marketing end
- 2026-09-30
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine Antifungal [EPC], Allylamine [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terbinafine
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERBINAFINE HYDROCHLORIDE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 012C11ZU6G |
| Rxcui | 313222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4323-0 | Terbinafine | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 1 |
| 70518-4323-1 | Terbinafine | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 1 |
| 70518-4323-2 | Terbinafine | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-4323-0 | 70518432300 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-4323-0) | 30 tablet | 2025-03-28 | 2026-09-30 | No | No | Historical |
| 70518-4323-1 | 70518432301 | 14 TABLET in 1 BOTTLE, PLASTIC (70518-4323-1) | 14 tablet | 2025-04-09 | 2026-09-30 | No | No | Historical |
| 70518-4323-2 | 70518432302 | 30 TABLET in 1 BLISTER PACK (70518-4323-2) | 30 tablet | 2025-05-15 | 2026-09-30 | No | No | Historical |