Tadalafil
- Product NDC
- 42291-787
- 11-digit product format
- 422910787
- Labeler code
- 42291
- Product ID
- 42291-787_c7026e67-7463-7fdc-e053-2a95a90a00d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA090141
- Marketing category
- ANDA
- Marketing start
- 2018-10-09
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b90b74cb-f6c8-3798-d11c-73b8768b278a | Product name | 8 | 20250317 |
| 0fe0157c-95a7-4870-ae64-de9f3fa874ae | Product name | 1 | 20250227 |
| 20ae0006-d78c-4dba-9e3e-6ae424841903 | Product name | 1 | 20250127 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| b86a08b7-54cc-440b-ad4a-3e530ccd8324 | Product name | 6 | 20230421 |
| 7a02e74a-2844-42af-84a8-96bae57351cf | Product name | 1 | 20230313 |
| 928d249c-35c3-4d88-a9ef-cf2f2e31b96f | Product name | 1 | 20220706 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42291-787-30 | EA - Each | 42291-787 | 108172fe-4706-4b77-b0db-0547dfaee72a | 1 | 2019-05-02 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402019 | tadalafil 20 MG Oral Tablet | PSN | 93b97b99-1bca-4390-abad-d52712818065 | 2 |
| 403957 | tadalafil 5 MG Oral Tablet | PSN | 93b97b99-1bca-4390-abad-d52712818065 | 2 |
| 402019 | tadalafil 20 MG Oral Tablet | SCD | 93b97b99-1bca-4390-abad-d52712818065 | 2 |
| 403957 | tadalafil 5 MG Oral Tablet | SCD | 93b97b99-1bca-4390-abad-d52712818065 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42291-787-30 | 42291078730 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-787-30) | 2018-10-09 | 0000-00-00 | No | No | Current |