Tadalafil
- Product NDC
- 71335-1491
- 11-digit product format
- 713351491
- Labeler code
- 71335
- Product ID
- 71335-1491_d3e06344-a4f3-4e0e-89c3-6079a7acc580
- 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
- 20 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
openFDA Listing Details
- Product ID
- 71335-1491_d3e06344-a4f3-4e0e-89c3-6079a7acc580
- 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
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| TADALAFIL | 20 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 402019 |
| Spl Set Id | 85ed0cbc-df84-44df-a9eb-f9587dbc21df |
| Manufacturer Name | Bryant Ranch Prepack |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1491-1 | 71335149101 | 30 TABLET in 1 BOTTLE (71335-1491-1) | 30 tablet | 2020-01-29 | 0000-00-00 | No | No | Current |
| 71335-1491-2 | 71335149102 | 10 TABLET in 1 BOTTLE (71335-1491-2) | 10 tablet | 2020-02-25 | 0000-00-00 | No | No | Current |
| 71335-1491-3 | 71335149103 | 90 TABLET in 1 BOTTLE (71335-1491-3) | 90 tablet | 2020-06-03 | 0000-00-00 | No | No | Current |
| 71335-1491-4 | 71335149104 | 5 TABLET in 1 BOTTLE (71335-1491-4) | 5 tablet | 2021-08-30 | 0000-00-00 | No | No | Current |
| 71335-1491-5 | 71335149105 | 60 TABLET in 1 BOTTLE (71335-1491-5) | 60 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |
| 71335-1491-6 | 71335149106 | 20 TABLET in 1 BOTTLE (71335-1491-6) | 20 tablet | 2021-09-23 | 0000-00-00 | No | No | Current |
| 71335-1491-7 | 71335149107 | 15 TABLET in 1 BOTTLE (71335-1491-7) | 15 tablet | 2021-03-29 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tadalafil | Bryant Ranch Prepack | 2024-08-21 | HUMAN PRESCRIPTION DRUG LABEL | 8 |