Tadalafil
- Product NDC
- 68071-2451
- 11-digit product format
- 680712451
- Labeler code
- 68071
- Product ID
- 68071-2451_c4d5d1fd-65e1-70cc-e053-2995a90a5ded
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tadalafil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA209654
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Marketing end
- 0000-00-00
- Substance
- TADALAFIL
- Active strength
- 5 mg/1
- Pharmacologic classes
- Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68071-2451 | I | Inactivated by FDA | 2026-09-14 | ||
| excluded package | package | 68071-2451 | 68071-2451-3 | I | Inactivated by FDA | 2026-09-14 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2451-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2451-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68071-2451-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68071-2451-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-2451-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-2451-3 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-2451-3 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209654-001 | TADALAFIL | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209654-002 | TADALAFIL | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209654-003 | TADALAFIL | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209654-004 | TADALAFIL | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209654-001 | AB1 |
| A209654-002 | AB1 |
| A209654-003 | AB1 |
| A209654-004 | AB1 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209654-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209654-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209654-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209654-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209654-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209654-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209654-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A209654-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209654-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209654-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209654-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A209654-004 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209654-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209654-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209654-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209654-004 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209654-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209654-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209654-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209654-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209654-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209654-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209654-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209654-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209654-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209654-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209654-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209654-004 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209654-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209654-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209654-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209654-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209654-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209654-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209654-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209654-004 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209654-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209654-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209654-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209654-004 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209654-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209654-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209654-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209654-004 | AB1 | 1 | 5bbf6a4d5a75… |
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 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2451-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-c986-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2451-3 | Tadalafil | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2451 | TADALAFIL TABLET [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC, 1 package rows | 20210616_c4d5d1fd-65e0-70cc-e053-2995a90a5ded.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tadalafil | TADALAFIL | A-S Medication Solutions | b1840f16-a7ea-44bd-b091-5268990aedb2 | 2026-09-09 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | c3409762-3b2b-1cfc-e053-2995a90ab91b | 2026-08-18 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | d6e8c52f-4dc3-5d54-e053-2995a90a9358 | 2026-08-03 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | REMEDYREPACK INC. | 415bd983-86f3-4f38-917a-9805024f31cb | 2026-07-09 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | REMEDYREPACK INC. | ad288e9d-020a-43a0-9c07-320c5c3bbc1e | 2026-05-27 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | 2c2ec257-06bc-4ca4-9cf3-d0f49980e374 | 2026-05-14 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | c835a34a-9bae-4d88-b951-1b78ab92f388 | 2026-05-13 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | PD-Rx Pharmaceuticals, Inc. | f34e4747-28be-4ae5-ac9a-a825083b6a9b | 2026-01-12 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | PD-Rx Pharmaceuticals, Inc. | 7e236f83-14bf-4862-91fb-74d766aef6a9 | 2026-01-12 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | cf353da9-31c6-66c2-e053-2995a90a3bb0 | 2026-01-09 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Quallent Pharmaceuticals Health LLC | dc14daa3-cae9-4751-9034-b0e9c18054b4 | 2025-11-30 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Ajanta Pharma USA Inc. | 7e4cdac1-42cc-4038-a86b-4890962ed806 | 2025-10-10 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Preferred Pharmaceuticals Inc. | 2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8 | 2025-09-25 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Preferred Pharmaceuticals Inc. | 761dc0f8-2f65-4615-ab49-a4bcffd40ce9 | 2025-09-25 | Warnings, Adverse reactions | 209654 ANDA209654 |
| TADALAFIL | TADALAFIL | direct rx | b3ee8325-bcb2-43fd-e053-2a95a90a08c8 | 2025-07-09 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | 0a9cf85a-c17d-6890-e063-6394a90a93e9 | 2025-03-04 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | 85ed0cbc-df84-44df-a9eb-f9587dbc21df | 2024-08-21 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Bryant Ranch Prepack | 185a3284-3a4f-44d3-9278-98581d33f95b | 2024-08-08 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Aphena Pharma Solutions - Tennessee, LLC | 6213fd38-9580-4253-91d2-14c28a711c20 | 2023-08-28 | Warnings, Adverse reactions | 209654 ANDA209654 |
| Tadalafil | TADALAFIL | Asclemed USA, Inc. | 5ea24573-2d16-40d8-a46c-7b5fa8669e69 | 2023-03-28 | Warnings, Adverse reactions | 209654 ANDA209654 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403957 | tadalafil 5 MG Oral Tablet | PSN | c4d5d1fd-65e0-70cc-e053-2995a90a5ded | 1 |
| 403957 | tadalafil 5 MG Oral Tablet | SCD | c4d5d1fd-65e0-70cc-e053-2995a90a5ded | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-2451-3 | 68071245103 | 30 TABLET in 1 BOTTLE (68071-2451-3) | 30 tablet | 2021-06-15 | 0000-00-00 | No | No | Current |