Terbinafine
- Product NDC
- 60687-909
- 11-digit product format
- 606870909
- Labeler code
- 60687
- Product ID
- 60687-909_4c60628e-6530-5ef1-e063-6294a90a7984
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078297
- Marketing category
- ANDA
- Marketing start
- 2026-03-01
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine Antifungal [EPC], Allylamine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terbinafine
- Listing expiration
- 2027-12-31
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 |
|---|
| 60687-909-11 | Terbinafine | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 60687-909-21 | Terbinafine | 30 in 1 CARTON | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-909-11 | 60687090911 | 1 in 1 BLISTER PACK | | | | | Historical |
| 60687-909-21 | 60687090921 | 30 BLISTER PACK in 1 CARTON (60687-909-21) / 1 TABLET in 1 BLISTER PACK (60687-909-11) | 30 blister pack | 2026-03-01 | No | No | Historical |