tadalafil
- Product NDC
- 29300-287
- 11-digit product format
- 293000287
- Labeler code
- 29300
- Product ID
- 29300-287_6fee8842-9e23-43d9-a4ff-4e147bf9f6a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- 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 | 402019, 403957, 484814, 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-287-01 | tadalafil | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 13 |
| 29300-287-05 | tadalafil | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 13 |
| 29300-287-13 | tadalafil | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 13 |
| 29300-287-51 | tadalafil | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 13 |
| 29300-287-82 | tadalafil | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-287 | TADALAFIL TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 13 | Current NDC, Legacy NDC, 5 package rows | 20240201_a7b3937e-ff03-436a-a5d4-92a4771034b6.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 |
|---|
| 29300-287-01 | 29300028701 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-287-01) | | 2019-03-26 | 0000-00-00 | No | No | Current |
| 29300-287-05 | 29300028705 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-287-05) | | 2019-03-26 | 0000-00-00 | No | No | Current |
| 29300-287-13 | 29300028713 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-287-13) | | 2019-03-26 | 0000-00-00 | No | No | Current |
| 29300-287-51 | 29300028751 | 15 in 1 BLISTER PACK | | | | | | Historical |
| 29300-287-82 | 29300028782 | 2 BLISTER PACK in 1 CARTON (29300-287-82) / 15 TABLET, FILM COATED in 1 BLISTER PACK (29300-287-51) | 2 blister pack | 2019-03-26 | 0000-00-00 | No | No | Current |