Tadalafil
- Product NDC
- 0093-3017
- 11-digit product format
- 000933017
- Labeler code
- 0093
- Product ID
- 0093-3017_08e8069b-c417-4cb8-8423-ffc540232a6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA090141
- Marketing category
- ANDA
- Marketing start
- 2018-09-27
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 5 mg/1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3017 | TADALAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 16 | Legacy NDC | 20241211_247ec8fe-e44c-4341-b992-2d6fd6d5f2ba.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-3017-56 | 00093301756 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-3017-56) | | 2018-09-27 | 0000-00-00 | No | No | Current |
| 0093-3017-65 | 00093301765 | 2 BLISTER PACK in 1 BOX (0093-3017-65) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0093-3017-30) | 2 blister pack | 2018-09-27 | 0000-00-00 | No | No | Current |