TADALAFIL
- Product NDC
- 72303-0823
- 11-digit product format
- 723030823
- Labeler code
- 72303
- Product ID
- 72303-0823_4c53221b-7a21-9531-e063-6294a90a9ac4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- HEC Pharm USA Inc.
- Application
- ANDA211335
- Marketing category
- ANDA
- Marketing start
- 2019-03-27
- Substance
- TADALAFIL
- Active strength
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TADALAFIL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TADALAFIL | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 742SXX0ICT |
| Rxcui | 402019, 403957, 484814, 757707 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b90b74cb-f6c8-3798-d11c-73b8768b278a | Product name | 8 | 20250317 |
| 0fe0157c-95a7-4870-ae64-de9f3fa874ae | Product name | 1 | 20250227 |
| 20ae0006-d78c-4dba-9e3e-6ae424841903 | Product name | 1 | 20250127 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| b86a08b7-54cc-440b-ad4a-3e530ccd8324 | Product name | 6 | 20230421 |
| 7a02e74a-2844-42af-84a8-96bae57351cf | Product name | 1 | 20230313 |
| 928d249c-35c3-4d88-a9ef-cf2f2e31b96f | Product name | 1 | 20220706 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72303-0823-1 | TADALAFIL | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72303-0823-1 | EA - Each | 72303-0823 | cf695b46-f9da-4fb1-af20-10d346d37bff | 1 | 2026-04-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 484814 | tadalafil 10 MG Oral Tablet | PSN | a0f728b6-2cc6-cb65-e053-2a95a90ab142 | 4 |
| 757707 | tadalafil 2.5 MG Oral Tablet | PSN | a0f728b6-2cc6-cb65-e053-2a95a90ab142 | 4 |
| 402019 | tadalafil 20 MG Oral Tablet | PSN | a0f728b6-2cc6-cb65-e053-2a95a90ab142 | 4 |
| 403957 | tadalafil 5 MG Oral Tablet | PSN | a0f728b6-2cc6-cb65-e053-2a95a90ab142 | 4 |
| 484814 | tadalafil 10 MG Oral Tablet | SCD | a0f728b6-2cc6-cb65-e053-2a95a90ab142 | 4 |
| 757707 | tadalafil 2.5 MG Oral Tablet | SCD | a0f728b6-2cc6-cb65-e053-2a95a90ab142 | 4 |
| 402019 | tadalafil 20 MG Oral Tablet | SCD | a0f728b6-2cc6-cb65-e053-2a95a90ab142 | 4 |
| 403957 | tadalafil 5 MG Oral Tablet | SCD | a0f728b6-2cc6-cb65-e053-2a95a90ab142 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72303-0823-1 | 72303082301 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72303-0823-1) | 2019-03-27 | 0000-00-00 | No | No | Current |