Tadalafil
- Product NDC
- 43598-576
- 11-digit product format
- 435980576
- Labeler code
- 43598
- Product ID
- 43598-576_7d8af9db-e459-1195-41b8-67f96e390ef2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA210069
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- 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 |
|---|
| 43598-576-30 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 43598-576-31 | Tadalafil | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 8 |
| 43598-576-79 | Tadalafil | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-576 | TADALAFIL TABLET, FILM COATED [DR.REDDYS LABORATORIES INC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20211130_22b8a2e3-d1b8-f193-45fa-77cc62a1b941.zip |
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 |
|---|
| 43598-576-30 | 43598057630 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-576-30) | | 2019-03-26 | 0000-00-00 | No | No | Current |
| 43598-576-31 | 43598057631 | 3 BLISTER PACK in 1 CARTON (43598-576-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-576-79) | 3 blister pack | 2020-04-07 | 0000-00-00 | No | No | Current |
| 43598-576-79 | 43598057679 | 10 in 1 BLISTER PACK | | | | | | Historical |