tadalafil
- Product NDC
- 76420-856
- 11-digit product format
- 764200856
- Labeler code
- 76420
- Product ID
- 76420-856_38689a7c-8af1-e4b0-e063-6394a90a94d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA209250
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 10 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 | 10 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 |
|---|
| 76420-856-01 | tadalafil | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 2 |
| 76420-856-05 | tadalafil | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 2 |
| 76420-856-30 | tadalafil | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 76420-856-60 | tadalafil | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 2 |
| 76420-856-90 | tadalafil | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-856 | TADALAFIL TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Current NDC, 5 package rows | 20250131_fa547e3d-455a-4926-9fd9-349930898502.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-856-01 | 76420085601 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-01) | 2025-01-28 | No | No | Historical |
| 76420-856-05 | 76420085605 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-05) | 2025-01-28 | No | No | Historical |
| 76420-856-30 | 76420085630 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-30) | 2025-01-28 | No | No | Historical |
| 76420-856-60 | 76420085660 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-60) | 2025-01-28 | No | No | Historical |
| 76420-856-90 | 76420085690 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-90) | 2025-01-28 | No | No | Historical |