Tadalafil
- Product NDC
- 72865-104
- 11-digit product format
- 728650104
- Labeler code
- 72865
- Product ID
- 72865-104_28d63724-c672-207c-e063-6294a90af28d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals Inc.
- Application
- ANDA209908
- Marketing category
- ANDA
- Marketing start
- 2024-12-10
- 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 |
|---|
| 72865-104-30 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-104 | TADALAFIL (TADALAFIL) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20241210_add6afb8-d38c-47a2-8c35-d5940667bb0c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72865-104-30 | 72865010430 | 30 TABLET, FILM COATED in 1 BOTTLE (72865-104-30) | 2024-12-10 | No | No | Current |