Tadalafil
- Product NDC
- 71335-1823
- 11-digit product format
- 713351823
- Labeler code
- 71335
- Product ID
- 71335-1823_bb3b7333-03a8-465c-8845-7b9be87999af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209654
- 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
- 2027-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-1823_bb3b7333-03a8-465c-8845-7b9be87999af
- SPL ID
- bb3b7333-03a8-465c-8845-7b9be87999af
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Tadalafil
- Generic name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2019-03-26
- Marketing category
- ANDA
- Application number
- ANDA209654
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC]; Phosphodiesterase 5 Inhibitors [MoA]
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| TADALAFIL | 2.5 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 757707 |
| Spl Set Id | 2c2ec257-06bc-4ca4-9cf3-d0f49980e374 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1823-1 | 90 TABLET in 1 BOTTLE (71335-1823-1) | 2021-12-21 | No |
| 71335-1823-2 | 30 TABLET in 1 BOTTLE (71335-1823-2) | 2021-12-21 | No |
| 71335-1823-3 | 10 TABLET in 1 BOTTLE (71335-1823-3) | 2021-12-21 | No |
| 71335-1823-4 | 20 TABLET in 1 BOTTLE (71335-1823-4) | 2021-12-21 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 742SXX0ICT | TADALAFIL | 171596-29-5 | TADALAFIL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1823-1 | 71335182301 | 90 TABLET in 1 BOTTLE (71335-1823-1) | 90 tablet | 2021-12-21 | No | No | Historical |
| 71335-1823-2 | 71335182302 | 30 TABLET in 1 BOTTLE (71335-1823-2) | 30 tablet | 2021-12-21 | No | No | Historical |
| 71335-1823-3 | 71335182303 | 10 TABLET in 1 BOTTLE (71335-1823-3) | 10 tablet | 2021-12-21 | No | No | Historical |
| 71335-1823-4 | 71335182304 | 20 TABLET in 1 BOTTLE (71335-1823-4) | 20 tablet | 2021-12-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tadalafil | Bryant Ranch Prepack | 2026-05-14 | HUMAN PRESCRIPTION DRUG LABEL | 103 |