TADALAFIL
- Product NDC
- 70518-3864
- 11-digit product format
- 705183864
- Labeler code
- 70518
- Product ID
- 70518-3864_3f8ca6f6-bd76-cc58-e063-6294a90a725e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA210609
- Marketing category
- ANDA
- Marketing start
- 2023-09-18
- Substance
- TADALAFIL
- Active strength
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 742SXX0ICT |
| Rxcui | 403957 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3864-0 | TADALAFIL | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3864 | TADALAFIL TABLET [REMEDYREPACK INC.] | 2 | Current NDC, 1 package rows | 20240403_89a33a41-0f01-4f29-8b2f-769d649fbdcb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3864-0 | 70518386400 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-3864-0) | 30 tablet | 2023-09-18 | No | No | Historical |