tadalafil
- Product NDC
- 71205-754
- 11-digit product format
- 712050754
- Labeler code
- 71205
- Product ID
- 71205-754_ac93704f-8e33-43ba-8b56-3d61092ff1d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA209250
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 403957 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-754-10 | tadalafil | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 1 |
| 71205-754-20 | tadalafil | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 1 |
| 71205-754-30 | tadalafil | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 71205-754-60 | tadalafil | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 71205-754-90 | tadalafil | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-754 | TADALAFIL TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 5 package rows | 20230204_ac93704f-8e33-43ba-8b56-3d61092ff1d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-754-10 | 71205075410 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-10) | 2023-01-31 | No | No | Current |
| 71205-754-20 | 71205075420 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-20) | 2023-01-31 | No | No | Current |
| 71205-754-30 | 71205075430 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-30) | 2023-01-31 | No | No | Current |
| 71205-754-60 | 71205075460 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-60) | 2023-01-31 | No | No | Current |
| 71205-754-90 | 71205075490 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-754-90) | 2023-01-31 | No | No | Current |