Tadalafil

Product NDC: 75834-249
11-digit product format: 758340249
Labeler code: 75834
Product ID: 75834-249_45810509-9e49-3ee2-e063-6394a90aa944
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NIVAGEN PHARMACEUTICALS, INC.
Application: ANDA211298
Marketing category: ANDA
Marketing start: 2020-11-02
Substance: TADALAFIL
Active strength: 10 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 42.

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
A211298-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2020-10-23
A211298-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2020-10-23
A211298-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2020-10-23
A211298-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2020-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211298-001	AB1
A211298-002	AB1
A211298-003	AB1
A211298-004	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 4 · 148 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
2026-08-18 06:07:40	2026-07	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2020-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211298-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2020-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211298-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2020-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211298-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2020-10-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2020-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211298-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2020-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211298-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2020-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211298-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2020-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2020-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211298-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2020-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211298-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2020-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211298-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2020-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	BX	2020-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211298-002	TADALAFIL	5MG	TABLET / ORAL	BX	2020-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211298-003	TADALAFIL	10MG	TABLET / ORAL	BX	2020-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211298-004	TADALAFIL	20MG	TABLET / ORAL	BX	2020-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	BX	2020-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211298-002	TADALAFIL	5MG	TABLET / ORAL	BX	2020-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211298-003	TADALAFIL	10MG	TABLET / ORAL	BX	2020-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211298-004	TADALAFIL	20MG	TABLET / ORAL	BX	2020-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	BX	2020-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211298-002	TADALAFIL	5MG	TABLET / ORAL	BX	2020-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211298-003	TADALAFIL	10MG	TABLET / ORAL	BX	2020-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211298-004	TADALAFIL	20MG	TABLET / ORAL	BX	2020-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	BX	2020-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211298-002	TADALAFIL	5MG	TABLET / ORAL	BX	2020-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211298-003	TADALAFIL	10MG	TABLET / ORAL	BX	2020-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211298-004	TADALAFIL	20MG	TABLET / ORAL	BX	2020-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	BX	2020-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211298-002	TADALAFIL	5MG	TABLET / ORAL	BX	2020-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211298-003	TADALAFIL	10MG	TABLET / ORAL	BX	2020-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211298-004	TADALAFIL	20MG	TABLET / ORAL	BX	2020-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	BX	2020-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211298-002	TADALAFIL	5MG	TABLET / ORAL	BX	2020-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211298-003	TADALAFIL	10MG	TABLET / ORAL	BX	2020-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211298-004	TADALAFIL	20MG	TABLET / ORAL	BX	2020-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211298-001	TADALAFIL	2.5MG	TABLET / ORAL	BX	2020-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211298-002	TADALAFIL	5MG	TABLET / ORAL	BX	2020-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211298-003	TADALAFIL	10MG	TABLET / ORAL	BX	2020-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211298-004	TADALAFIL	20MG	TABLET / ORAL	BX	2020-10-23	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211298-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211298-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211298-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211298-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211298-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211298-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211298-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211298-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211298-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211298-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211298-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211298-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211298-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211298-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211298-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211298-004	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211298-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211298-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211298-003	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211298-004	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211298-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211298-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211298-003	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211298-004	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211298-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211298-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211298-003	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211298-004	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211298-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211298-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211298-003	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211298-004	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211298-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211298-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211298-003	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211298-004	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211298-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211298-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211298-003	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211298-004	BX	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tadalafil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	10 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
ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	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
75834-249-01	Tadalafil	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	10
75834-249-10	Tadalafil	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	10
75834-249-30	Tadalafil	30 in 1 BOTTLE	TABLET, FILM COATED	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-249-01	EA - Each	75834-249	52eda49d-9f73-4a20-b79e-3770036aa861	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-249	TADALAFIL TABLET, FILM COATED [NIVAGEN PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20241225_ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	NorthStar Rx, LLC	a10d464a-6ea7-4e5a-befa-71eceacc5039	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211298 application number: ANDA211298
Tadalafil	TADALAFIL	Umedica Laboratories USA Inc.	6caf3b55-9bf4-4355-9e25-8bf368943fdd	2026-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211298 application number: ANDA211298
Tadalafil	TADALAFIL	NIVAGEN PHARMACEUTICALS, INC.	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211298 application number: ANDA211298 ndc (product): 75834-249
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	e899da81-a28e-4a7e-a0e6-ed6d557c0bcd	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211298 application number: ANDA211298
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	828f0ee1-b9fc-4743-9394-fc086bcf5345	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211298 application number: ANDA211298
Tadalafil	TADALAFIL	Proficient Rx LP	a930511d-110e-4d2e-a4ca-df712f968b2d	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211298 application number: ANDA211298
Tadalafil	TADALAFIL	Proficient Rx LP	78b6659c-3a46-4998-9151-1a53afd83375	2024-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211298 application number: ANDA211298
Tadalafil	TADALAFIL	Proficient Rx LP	7dfb450b-4d39-40e7-b115-9a96023052a0	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211298 application number: ANDA211298

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	828f0ee1-b9fc-4743-9394-fc086bcf5345	10
484814	tadalafil 10 MG Oral Tablet	PSN	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	10
757707	tadalafil 2.5 MG Oral Tablet	PSN	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	10
402019	tadalafil 20 MG Oral Tablet	PSN	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	10
403957	tadalafil 5 MG Oral Tablet	PSN	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	10
484814	tadalafil 10 MG Oral Tablet	SCD	828f0ee1-b9fc-4743-9394-fc086bcf5345	10
484814	tadalafil 10 MG Oral Tablet	SCD	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	10
757707	tadalafil 2.5 MG Oral Tablet	SCD	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	10
402019	tadalafil 20 MG Oral Tablet	SCD	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	10
403957	tadalafil 5 MG Oral Tablet	SCD	ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a	10
484814	tadalafil 10 MG Oral Tablet	PSN	a930511d-110e-4d2e-a4ca-df712f968b2d	2
484814	tadalafil 10 MG Oral Tablet	SCD	a930511d-110e-4d2e-a4ca-df712f968b2d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-249-01	75834024901	1000 TABLET, FILM COATED in 1 BOTTLE (75834-249-01)	2020-11-02	0000-00-00	No	No	Current
75834-249-10	75834024910	30 TABLET, FILM COATED in 1 BLISTER PACK (75834-249-10)	2020-11-02	0000-00-00	No	No	Current
75834-249-30	75834024930	30 TABLET, FILM COATED in 1 BOTTLE (75834-249-30)	2020-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tadalafil	NIVAGEN PHARMACEUTICALS, INC. \| UMEDICA LABORATORIES PRIVATE LIMITED	2025-12-09	HUMAN PRESCRIPTION DRUG LABEL	10
Tadalafil	PD-Rx Pharmaceuticals, Inc.	2025-04-08	HUMAN PRESCRIPTION DRUG LABEL	10
Tadalafil	Proficient Rx LP	2024-04-01	HUMAN PRESCRIPTION DRUG LABEL	2