Tadalafil

Product NDC: 68788-8292
11-digit product format: 687888292
Labeler code: 68788
Product ID: 68788-8292_0f68ca87-9c30-4ad8-b72f-19ee28d15b3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA209654
Marketing category: ANDA
Marketing start: 2022-11-28
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	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#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	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#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
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…`

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
742SXX0ICT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
403957	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-8292-1	Tadalafil	15 in 1 BOTTLE	TABLET	15	4
68788-8292-2	Tadalafil	20 in 1 BOTTLE	TABLET	20	4
68788-8292-3	Tadalafil	30 in 1 BOTTLE	TABLET	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8292-1	EA - Each	68788-8292	20165e38-9c73-4130-8fc1-8e0ab71a02a3	1	2023-01-09
68788-8292-2	EA - Each	68788-8292	c113d333-8b01-4593-9e0b-ddb5cb66c4f1	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8292	TADALAFIL TABLET [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 3 package rows	20240816_2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8.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.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	c3409762-3b2b-1cfc-e053-2995a90ab91b	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	d6e8c52f-4dc3-5d54-e053-2995a90a9358	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	REMEDYREPACK INC.	415bd983-86f3-4f38-917a-9805024f31cb	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	REMEDYREPACK INC.	ad288e9d-020a-43a0-9c07-320c5c3bbc1e	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	2c2ec257-06bc-4ca4-9cf3-d0f49980e374	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	c835a34a-9bae-4d88-b951-1b78ab92f388	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	f34e4747-28be-4ae5-ac9a-a825083b6a9b	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	7e236f83-14bf-4862-91fb-74d766aef6a9	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf353da9-31c6-66c2-e053-2995a90a3bb0	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Quallent Pharmaceuticals Health LLC	dc14daa3-cae9-4751-9034-b0e9c18054b4	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Ajanta Pharma USA Inc.	7e4cdac1-42cc-4038-a86b-4890962ed806	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654 ndc (product): 68788-8292
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	761dc0f8-2f65-4615-ab49-a4bcffd40ce9	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
TADALAFIL	TADALAFIL	direct rx	b3ee8325-bcb2-43fd-e053-2a95a90a08c8	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	0a9cf85a-c17d-6890-e063-6394a90a93e9	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	85ed0cbc-df84-44df-a9eb-f9587dbc21df	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	185a3284-3a4f-44d3-9278-98581d33f95b	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	6213fd38-9580-4253-91d2-14c28a711c20	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Asclemed USA, Inc.	5ea24573-2d16-40d8-a46c-7b5fa8669e69	2023-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
742SXX0ICT	TADALAFIL	171596-29-5	TADALAFIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403957	tadalafil 5 MG Oral Tablet	PSN	2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8	4
403957	tadalafil 5 MG Oral Tablet	SCD	2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8292-1	68788829201	15 TABLET in 1 BOTTLE (68788-8292-1)	15 tablet	2022-11-28	0000-00-00	No	No	Current
68788-8292-2	68788829202	20 TABLET in 1 BOTTLE (68788-8292-2)	20 tablet	2022-11-28	0000-00-00	No	No	Current
68788-8292-3	68788829203	30 TABLET in 1 BOTTLE (68788-8292-3)	30 tablet	2024-08-15		No	No	Current