Tadalafil
- Product NDC
- 0093-3016
- 11-digit product format
- 000933016
- Labeler code
- 0093
- Product ID
- 0093-3016_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
- 3 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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| unfinished product | product | 0093-3016 | | UNFINISHED | Active or certified unfinished drug listing | | 2026-07-31 |
| unfinished package | package | 0093-3016 | 0093-3016-99 | UNFINISHED | Active or certified unfinished drug listing | | 2026-07-31 |
| excluded product | product | 0093-3016 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0093-3016 | 0093-3016-65 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A090141-001 | TADALAFIL | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | | 2018-05-22 |
| A090141-002 | TADALAFIL | TADALAFIL | 5MG | TABLET / ORAL | AB1 | | 2018-05-22 |
| A090141-003 | TADALAFIL | TADALAFIL | 10MG | TABLET / ORAL | AB1 | | 2018-05-22 |
| A090141-004 | TADALAFIL | TADALAFIL | 20MG | TABLET / ORAL | AB1 | | 2018-05-22 |
Therapeutic equivalence codes#
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 2.5 mg/1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-3016 | 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 |
|---|
| 0093-3016-65 | 00093301665 | 2 BLISTER PACK in 1 BOX (0093-3016-65) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0093-3016-30) | 2 blister pack | 2018-09-27 | 0000-00-00 | No | No | Current |
| 0093-3016-99 | 00093301699 | 483870 TABLET, FILM COATED in 1 DRUM (0093-3016-99) | | 10-AUG-18 | | | | Current |