Tadalafil
- Product NDC
- 68382-897
- 11-digit product format
- 683820897
- Labeler code
- 68382
- Product ID
- 68382-897_5a958db7-5c0e-4cf0-9227-230886cf9bf8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA206693
- Marketing category
- ANDA
- Marketing start
- 2019-03-27
- 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 |
|---|
| 68382-897-01 | Tadalafil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 68382-897-05 | Tadalafil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
| 68382-897-06 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68382-897-10 | Tadalafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
| 68382-897-16 | Tadalafil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
| 68382-897-50 | Tadalafil | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 4 |
| 68382-897-99 | Tadalafil | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 4 |
| 68382-897-99 | Tadalafil | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-897 | TADALAFIL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 8 package rows | 20231110_cfe43ab8-8721-4db8-8810-f0072cf8f4d3.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 |
|---|
| 68382-897-01 | 68382089701 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-897-01) | | 2019-03-27 | 0000-00-00 | No | No | Current |
| 68382-897-05 | 68382089705 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-897-05) | | 2019-03-27 | 0000-00-00 | No | No | Current |
| 68382-897-06 | 68382089706 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-897-06) | | 2019-03-27 | 0000-00-00 | No | No | Current |
| 68382-897-10 | 68382089710 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-897-10) | | 2019-03-27 | 0000-00-00 | No | No | Current |
| 68382-897-16 | 68382089716 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-897-16) | | 2019-03-27 | 0000-00-00 | No | No | Current |
| 68382-897-50 | 68382089750 | 10 TABLET, FILM COATED in 1 BOTTLE (68382-897-50) | | 2019-03-27 | 0000-00-00 | No | No | Current |
| 68382-897-99 | 68382089799 | 2 BLISTER PACK in 1 CARTON (68382-897-99) / 15 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2019-03-27 | 0000-00-00 | No | No | Current |