tadalafil

Product NDC: 76420-855
11-digit product format: 764200855
Labeler code: 76420
Product ID: 76420-855_38689a7c-8af1-e4b0-e063-6394a90a94d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA209250
Marketing category: ANDA
Marketing start: 2019-03-26
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 1.

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
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#

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

Application-product, TE code table
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.

Product history page 1 of 5 · 164 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
2026-02-19 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#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
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…`

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402019	Internal RxNorm lookup
403957	Internal RxNorm lookup
484814	Internal RxNorm lookup
757707	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
fa547e3d-455a-4926-9fd9-349930898502	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
76420-855-01	tadalafil	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	2
76420-855-05	tadalafil	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	2
76420-855-30	tadalafil	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
76420-855-33	tadalafil	2 in 1 CARTON	TABLET, FILM COATED	2	2
76420-855-33	tadalafil	15 in 1 BLISTER PACK	TABLET, FILM COATED	15	2
76420-855-60	tadalafil	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	2
76420-855-90	tadalafil	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-855	TADALAFIL TABLET, FILM COATED [ASCLEMED USA, INC.]	1	Current NDC, 7 package rows	20250131_fa547e3d-455a-4926-9fd9-349930898502.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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	fee8c2be-ccfa-4c66-abed-5e232ec762ae	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	2c277890-3c5d-5fd5-e063-6394a90af15b	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	Asclemed USA, Inc.	fa547e3d-455a-4926-9fd9-349930898502	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250 ndc (product): 76420-855
tadalafil	TADALAFIL	Proficient Rx LP	7976c4ec-ecc4-4a49-a4fe-f990aece2d3c	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	Bryant Ranch Prepack	24b82a6a-1b7e-42e6-b29b-41d4ee4d525f	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	Bryant Ranch Prepack	ff3c7dd3-2dcc-498c-a121-1e2aa62c7a97	2024-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	Proficient Rx LP	929e391e-b74b-4ccd-8690-16ffcece7a30	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	13a107ba-cbbd-7760-e063-6394a90a1ee8	2024-03-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	Unichem Pharmaceuticals (USA), Inc.	a7b3937e-ff03-436a-a5d4-92a4771034b6	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250
tadalafil	TADALAFIL	Proficient Rx LP	ac93704f-8e33-43ba-8b56-3d61092ff1d9	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209250 application number: ANDA209250

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
484814	tadalafil 10 MG Oral Tablet	PSN	fa547e3d-455a-4926-9fd9-349930898502	2
757707	tadalafil 2.5 MG Oral Tablet	PSN	fa547e3d-455a-4926-9fd9-349930898502	2
402019	tadalafil 20 MG Oral Tablet	PSN	fa547e3d-455a-4926-9fd9-349930898502	2
403957	tadalafil 5 MG Oral Tablet	PSN	fa547e3d-455a-4926-9fd9-349930898502	2
484814	tadalafil 10 MG Oral Tablet	SCD	fa547e3d-455a-4926-9fd9-349930898502	2
757707	tadalafil 2.5 MG Oral Tablet	SCD	fa547e3d-455a-4926-9fd9-349930898502	2
402019	tadalafil 20 MG Oral Tablet	SCD	fa547e3d-455a-4926-9fd9-349930898502	2
403957	tadalafil 5 MG Oral Tablet	SCD	fa547e3d-455a-4926-9fd9-349930898502	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-855-01	76420085501	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-01)		2025-01-28	No	No	Current
76420-855-05	76420085505	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-05)		2025-01-28	No	No	Current
76420-855-30	76420085530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-30)		2025-01-28	No	No	Current
76420-855-33	76420085533	2 BLISTER PACK in 1 CARTON (76420-855-33) / 15 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2025-01-28	No	No	Current
76420-855-60	76420085560	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-60)		2025-01-28	No	No	Current
76420-855-90	76420085590	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-855-90)		2025-01-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tadalafil	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-06-25	HUMAN PRESCRIPTION DRUG LABEL	2