Tadalafil
- Product NDC
- 82868-028
- 11-digit product format
- 828680028
- Labeler code
- 82868
- Product ID
- 82868-028_46dca45a-dcd4-7994-e063-6294a90a573a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA206286
- Marketing category
- ANDA
- Marketing start
- 2023-11-16
- 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 | 402019 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82868-028-06 | Tadalafil | 6 in 1 BOTTLE, PLASTIC | TABLET | 6 | | 2 |
| 82868-028-15 | Tadalafil | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-028 | TADALAFIL TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20240110_0afd0728-256a-293b-e063-6394a90a3c5f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-028-06 | 82868002806 | 6 TABLET in 1 BOTTLE, PLASTIC (82868-028-06) | 6 tablet | 2023-11-21 | No | No | Historical |
| 82868-028-15 | 82868002815 | 15 TABLET in 1 BOTTLE, PLASTIC (82868-028-15) | 15 tablet | 2023-11-16 | No | No | Historical |