Tadalafil
- Product NDC
- 72789-396
- 11-digit product format
- 727890396
- Labeler code
- 72789
- Product ID
- 72789-396_483331a7-a3a5-f610-e063-6394a90aeeec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA209654
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tadalafil
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 402019 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-396-15 | Tadalafil | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | | 15 |
| 72789-396-90 | Tadalafil | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-396 | TADALAFIL TABLET [PD-RX PHARMACEUTICALS, INC.] | 13 | Current NDC, 2 package rows | 20240522_7e236f83-14bf-4862-91fb-74d766aef6a9.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 |
|---|
| 72789-396-15 | 72789039615 | 15 TABLET in 1 BOTTLE, PLASTIC (72789-396-15) | 15 tablet | 2024-04-30 | No | No | Current |
| 72789-396-90 | 72789039690 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-396-90) | 90 tablet | 2024-05-21 | No | No | Current |