Tadalafil
- Product NDC
- 0378-6973
- 11-digit product format
- 003786973
- Labeler code
- 0378
- Product ID
- 0378-6973_364264a9-0704-496d-b7f8-df4090453cf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206956
- Marketing category
- ANDA
- Marketing start
- 2019-05-14
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| excluded product | product | 0378-6973 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0378-6973 | 0378-6973-93 | 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 |
|---|
| A206956-001 | TADALAFIL | TADALAFIL | 2.5MG | TABLET / ORAL | | | 2019-04-29 |
| A206956-002 | TADALAFIL | TADALAFIL | 10MG | TABLET / ORAL | | | 2019-04-29 |
| A206956-003 | TADALAFIL | TADALAFIL | 20MG | TABLET / ORAL | | | 2019-04-29 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-6973-93 | 00378697393 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6973-93) | 2019-05-14 | 0000-00-00 | No | No | Current |