tadalafil
- Product NDC
- 67296-2237
- Requested package NDC
- 67296-2237-2
- 11-digit product format
- 672962237
- Labeler code
- 67296
- Product ID
- 67296-2237_52505a7a-e3de-7c4e-e063-6294a90a1473
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tadalafil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Redpharm Drug
- Application
- ANDA209250
- Marketing category
- ANDA
- Marketing start
- 2019-03-26
- Substance
- TADALAFIL
- Active strength
- 10 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209250-001 | TADALAFIL | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209250-002 | TADALAFIL | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209250-003 | TADALAFIL | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | |
| A209250-004 | TADALAFIL | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209250-001 | AB1 |
| A209250-002 | AB1 |
| A209250-003 | AB1 |
| A209250-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209250-001 | TADALAFIL | 2.5MG | TABLET / ORAL | AB1 | 2019-03-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209250-002 | TADALAFIL | 5MG | TABLET / ORAL | AB1 | 2019-03-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209250-003 | TADALAFIL | 10MG | TABLET / ORAL | AB1 | 2019-03-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209250-004 | TADALAFIL | 20MG | TABLET / ORAL | AB1 | 2019-03-26 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209250-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209250-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209250-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209250-004 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209250-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209250-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209250-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209250-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209250-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209250-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209250-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209250-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209250-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209250-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209250-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209250-004 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209250-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209250-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209250-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209250-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209250-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209250-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209250-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209250-004 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209250-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209250-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209250-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209250-004 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209250-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209250-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209250-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209250-004 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209250-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209250-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209250-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209250-004 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209250-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209250-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209250-003 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209250-004 | AB1 | 1 | d06236e962d9… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| tadalafil | TADALAFIL | Redpharm Drug | 52505a7a-e3dd-7c4e-e063-6294a90a1473 | 2026-05-21 | Warnings, Adverse reactions | 209250 ANDA209250 67296-2237-2 67296-2237 67296223702 |
| tadalafil | TADALAFIL | Preferred Pharmaceuticals Inc. | fee8c2be-ccfa-4c66-abed-5e232ec762ae | 2026-02-27 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | 2c277890-3c5d-5fd5-e063-6394a90af15b | 2025-07-21 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | Asclemed USA, Inc. | fa547e3d-455a-4926-9fd9-349930898502 | 2025-06-25 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | Proficient Rx LP | 7976c4ec-ecc4-4a49-a4fe-f990aece2d3c | 2025-06-01 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | Bryant Ranch Prepack | 24b82a6a-1b7e-42e6-b29b-41d4ee4d525f | 2025-04-03 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | Bryant Ranch Prepack | ff3c7dd3-2dcc-498c-a121-1e2aa62c7a97 | 2024-08-16 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | Proficient Rx LP | 929e391e-b74b-4ccd-8690-16ffcece7a30 | 2024-08-01 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | NuCare Pharmaceuticals,Inc. | 13a107ba-cbbd-7760-e063-6394a90a1ee8 | 2024-03-14 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | Unichem Pharmaceuticals (USA), Inc. | a7b3937e-ff03-436a-a5d4-92a4771034b6 | 2024-01-31 | Warnings, Adverse reactions | 209250 ANDA209250 |
| tadalafil | TADALAFIL | Proficient Rx LP | ac93704f-8e33-43ba-8b56-3d61092ff1d9 | 2023-01-01 | Warnings, Adverse reactions | 209250 ANDA209250 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- tadalafil
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TADALAFIL | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 742SXX0ICT | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 484814 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 52505a7a-e3dd-7c4e-e063-6294a90a1473 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-2237-2 | tadalafil | 5 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 5 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 484814 | tadalafil 10 MG Oral Tablet | PSN | 52505a7a-e3dd-7c4e-e063-6294a90a1473 | 1 |
| 484814 | tadalafil 10 MG Oral Tablet | SCD | 52505a7a-e3dd-7c4e-e063-6294a90a1473 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 67296-2237-2 | 67296223702 | 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67296-2237-2) | 2019-03-26 | No | No | Current |