Tadalafil
- Product NDC
- 65862-880
- 11-digit product format
- 658620880
- Labeler code
- 65862
- Product ID
- 65862-880_0e0e7730-aefd-4208-ad81-74fc8f114a13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206286
- Marketing category
- ANDA
- Marketing start
- 2019-02-05
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tadalafil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 2123194 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-880-60 | Tadalafil | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-880 | TADALAFIL TABLET [AUROBINDO PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240604_a0ecc7cf-20dd-485a-b4dd-1bbc587280a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-880-60 | 65862088060 | 60 TABLET in 1 BOTTLE (65862-880-60) | 60 tablet | 2019-02-05 | 0000-00-00 | No | No | Current |