N/A
- Product NDC
- 35561-256
- 11-digit product format
- 355610256
- Labeler code
- 35561
- Product ID
- 35561-256_49fc9e85-3dc2-064f-e063-6294a90af582
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bostal LLC
- Application
- ANDA208824
- Marketing category
- ANDA
- Marketing start
- 2019-11-29
- Substance
- TADALAFIL
- Active strength
- 10 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TADALAFIL | 10 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 |
|---|
| 35561-256-10 | N/A | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 5 |
| 35561-256-13 | N/A | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35561-256 | N/A (TADALAFIL) TABLET, FILM COATED [AUSTARPHARMA LLC] | 4 | Current NDC, 2 package rows | 20241222_78509a43-a907-4359-9022-f38c4f765880.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 35561-256-10 | 35561025610 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-256-10) | 2019-11-29 | No | No | Historical |
| 35561-256-13 | 35561025613 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35561-256-13) | 2019-11-29 | No | No | Historical |