Tadalafil
- Product NDC
- 76420-542
- 11-digit product format
- 764200542
- Labeler code
- 76420
- Product ID
- 76420-542_f7777037-65b9-9411-e053-6294a90a37eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA208934
- Marketing category
- ANDA
- Marketing start
- 2020-02-19
- Substance
- TADALAFIL
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tadalafil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 402019, 403957, 484814, 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-542-30 | Tadalafil | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 2 |
| 76420-542-30 | Tadalafil | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-542 | TADALAFIL TABLET, FILM COATED [ASCLEMED USA, INC.] | 2 | Current NDC, 2 package rows | 20230323_30ae58ed-5b56-4513-8eb3-eb4f89b78f9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-542-30 | 76420054230 | 2 BLISTER PACK in 1 CARTON (76420-542-30) / 15 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2023-03-14 | No | No | Historical |