Tadalafil
- Product NDC
- 51655-063
- 11-digit product format
- 516550063
- Labeler code
- 51655
- Product ID
- 51655-063_46ddbacb-b89b-1715-e063-6394a90a3c49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA206693
- Marketing category
- ANDA
- Marketing start
- 2022-09-27
- Substance
- TADALAFIL
- Active strength
- 20 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tadalafil
- Listing expiration
- 2027-12-31
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 |
|---|
| 51655-063-54 | Tadalafil | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 3 |
| 51655-063-87 | Tadalafil | 6 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-063 | TADALAFIL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20240704_f2a132af-d75e-2ca0-e053-2a95a90a332e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-063-54 | 51655006354 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-063-54) | 2022-09-27 | No | No | Historical |
| 51655-063-87 | 51655006387 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-063-87) | 2022-09-27 | No | No | Historical |