Tadalafil
- Product NDC
- 67184-0523
- 11-digit product format
- 671840523
- Labeler code
- 67184
- Product ID
- 67184-0523_3c59b310-6a02-451b-bc53-a29022509963
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA210420
- Marketing category
- ANDA
- Marketing start
- 2021-11-17
- 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 |
|---|
| 67184-0523-1 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 67184-0523-2 | Tadalafil | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 8 |
| 67184-0523-2 | Tadalafil | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0523 | TADALAFIL TABLET, FILM COATED [QILU PHARMACEUTICAL CO., LTD.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20220118_f295f164-78fb-4224-b319-9f20b7a453b5.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 |
|---|
| 67184-0523-1 | 67184052301 | 30 TABLET, FILM COATED in 1 BOTTLE (67184-0523-1) | | 2021-11-17 | 0000-00-00 | No | No | Current |
| 67184-0523-2 | 67184052302 | 2 BLISTER PACK in 1 CARTON (67184-0523-2) / 15 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2021-11-17 | 0000-00-00 | No | No | Current |