Tadalafil
- Product NDC
- 31722-643
- 11-digit product format
- 317220643
- Labeler code
- 31722
- Product ID
- 31722-643_a3892605-4eb1-4d6e-a675-f7f7d4302f38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA209908
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 2.5 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 | 2.5 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 |
|---|
| 31722-643-30 | Tadalafil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 31722-643-31 | Tadalafil | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 1 |
| 31722-643-31 | Tadalafil | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-643 | TADALAFIL TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 3 package rows | 20190402_a3892605-4eb1-4d6e-a675-f7f7d4302f38.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 |
|---|
| 31722-643-30 | 31722064330 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-643-30) | | 2019-03-26 | 0000-00-00 | No | No | Current |
| 31722-643-31 | 31722064331 | 3 BLISTER PACK in 1 CARTON (31722-643-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2019-03-26 | 0000-00-00 | No | No | Current |