TADALAFIL

Product NDC: 76420-546
Requested package NDC: 76420-546-90
11-digit product format: 764200546
Labeler code: 76420
Product ID: 76420-546_17d94690-32d0-14b1-e063-6294a90ae902
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TADALAFIL
Dosage form: TABLET
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA211839
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 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
A211839-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A211839-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A211839-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A211839-004	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
A211839-001	AB1
A211839-002	AB1
A211839-003	AB1
A211839-004	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	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211839-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211839-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211839-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211839-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211839-004	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	A211839-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211839-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211839-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211839-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211839-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211839-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211839-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211839-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211839-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211839-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211839-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211839-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211839-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211839-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211839-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211839-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211839-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211839-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211839-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211839-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211839-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211839-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211839-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211839-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211839-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211839-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211839-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211839-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211839-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211839-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211839-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211839-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211839-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211839-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211839-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211839-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211839-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211839-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211839-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211839-004	AB1	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
101f44e4-669c-4e3d-843a-a27157750f9c	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
76420-546-30	TADALAFIL	30 in 1 BOTTLE	TABLET	30	1
76420-546-60	TADALAFIL	60 in 1 BOTTLE	TABLET	60	1
76420-546-90	TADALAFIL	90 in 1 BOTTLE	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-546	TADALAFIL TABLET [ASCLEMED USA, INC.]	1	Current NDC, 3 package rows	20240508_101f44e4-669c-4e3d-843a-a27157750f9c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TADALAFIL	TADALAFIL	REMEDYREPACK INC.	82dfea4c-9fe5-438a-917f-8f7d395ee8ca	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211839 application number: ANDA211839
TADALAFIL	TADALAFIL	Torrent Pharmaceuticals Limited	3ea7612b-b004-43ef-accc-34c8ec5146b8	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211839 application number: ANDA211839
TADALAFIL	TADALAFIL	Preferred Pharmaceuticals Inc.	f9e9a953-2802-4bb1-91a3-a29be347801e	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211839 application number: ANDA211839
TADALAFIL	TADALAFIL	Asclemed USA, Inc.	101f44e4-669c-4e3d-843a-a27157750f9c	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211839 application number: ANDA211839 ndc (package): 76420-546-90 ndc (product): 76420-546 ndc11 (package): 76420054690

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	101f44e4-669c-4e3d-843a-a27157750f9c	1
403957	tadalafil 5 MG Oral Tablet	SCD	101f44e4-669c-4e3d-843a-a27157750f9c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-546-90	76420054690	90 TABLET in 1 BOTTLE (76420-546-90)	90 tablet	2023-03-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TADALAFIL	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-05-07	HUMAN PRESCRIPTION DRUG LABEL	1