Tadalafil
- Product NDC
- 43598-578
- 11-digit product format
- 435980578
- Labeler code
- 43598
- Product ID
- 43598-578_e0893959-da34-2bf9-3a3e-3b89974f13dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr.Reddys Laboratories Inc
- Application
- ANDA210145
- Marketing category
- ANDA
- Marketing start
- 2019-02-05
- Substance
- TADALAFIL
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 2123194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-578-30 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 43598-578-60 | Tadalafil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-578 | TADALAFIL TABLET, FILM COATED [DR.REDDYS LABORATORIES INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20201210_61955171-ca57-e300-1983-9472a56ca976.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-578-30 | 43598057830 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-578-30) | 2019-02-05 | 0000-00-00 | No | No | Current |
| 43598-578-60 | 43598057860 | 60 TABLET, FILM COATED in 1 BOTTLE (43598-578-60) | 2019-02-05 | 0000-00-00 | No | No | Current |