Tadalafil
- Product NDC
- 45865-991
- 11-digit product format
- 458650991
- Labeler code
- 45865
- Product ID
- 45865-991_9af2bdf7-addf-83f7-e053-2995a90a3c79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- medsource pharmaceuticals
- Application
- ANDA210420
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-991-30 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-991 | TADALAFIL TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 1 package rows | 20191231_9af2bdf7-adde-83f7-e053-2995a90a3c79.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45865-991-30 | 45865099130 | 30 TABLET, FILM COATED in 1 BOTTLE (45865-991-30) | 2019-12-11 | 0000-00-00 | No | No | Current |