Tadalafil
- Product NDC
- 16729-372
- 11-digit product format
- 167290372
- Labeler code
- 16729
- Product ID
- 16729-372_4f99c59f-9b38-f54a-e063-6294a90a60ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA209167
- Marketing category
- ANDA
- Marketing start
- 2019-03-27
- 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, 403957, 484814, 757707 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-372-10 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
| 16729-372-15 | Tadalafil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 15 |
| 16729-372-16 | Tadalafil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 16729-372-17 | Tadalafil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-372 | TADALAFIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20241006_eedf3ad9-7d40-496d-b1a9-6200010c18e1.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 |
|---|
| 16729-372-10 | 16729037210 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-372-10) | 2019-03-27 | 0000-00-00 | No | No | Current |
| 16729-372-15 | 16729037215 | 90 in 1 BOTTLE | | | | | Historical |
| 16729-372-16 | 16729037216 | 500 TABLET, FILM COATED in 1 BOTTLE (16729-372-16) | 2020-04-29 | 0000-00-00 | No | No | Current |
| 16729-372-17 | 16729037217 | 1000 in 1 BOTTLE | | | | | Historical |