Tadalafil

Product NDC: 71610-581
Requested package NDC: 71610-581-12
11-digit product format: 716100581
Labeler code: 71610
Product ID: 71610-581_21f23cde-ebd8-aa67-e063-6394a90a7150
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA209744
Marketing category: ANDA
Marketing start: 2021-01-21
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 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
A209744-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209744-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209744-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A209744-004	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
A209744-001	AB1
A209744-002	AB1
A209744-003	AB1
A209744-004	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	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209744-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209744-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209744-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209744-004	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	A209744-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209744-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209744-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209744-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209744-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209744-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209744-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209744-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209744-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209744-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209744-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209744-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209744-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209744-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209744-004	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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
484814	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
f2e8821e-04c9-4812-8c9e-39340775cc6e	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
71610-581-04	Tadalafil	4 in 1 BOTTLE	TABLET, FILM COATED	4	4
71610-581-06	Tadalafil	6 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	6	4
71610-581-12	Tadalafil	12 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	12	4
71610-581-39	Tadalafil	1440 in 1 BOTTLE	TABLET, FILM COATED	1440	4
71610-581-52	Tadalafil	18 in 1 BOTTLE	TABLET, FILM COATED	18	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-581-04	EA - Each	71610-581	8e44c90b-e6fd-41db-8842-bbd4c1994cd1	1	2021-09-07
71610-581-06	EA - Each	71610-581	23bf1e70-c5e5-4c00-8207-358cf78bcb98	1	2024-01-04
71610-581-12	EA - Each	71610-581	1f82e60b-61a3-40af-951b-492f7c684a47	1	2021-09-07
71610-581-39	EA - Each	71610-581	32ae54fe-2adb-4f47-a6cb-9b729bc8f7ba	1	2024-05-16
71610-581-52	EA - Each	71610-581	fc2d3af3-ea46-4ecc-9487-7dba4be4feaa	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-581	TADALAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Current NDC, Legacy NDC, 5 package rows	20240915_f2e8821e-04c9-4812-8c9e-39340775cc6e.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	Amneal Pharmaceuticals NY LLC	90f38460-62ad-492e-a3da-403d5a5a5d86	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744
Tadalafil	TADALAFIL	AvKARE	b96ae7f1-7d4a-a211-e053-2995a90ab6e2	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	bce03930-14c5-401f-ad17-06b7709983bc	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	f2e8821e-04c9-4812-8c9e-39340775cc6e	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744 ndc (package): 71610-581-12 ndc (product): 71610-581 ndc11 (package): 71610058112
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	d1dd9d05-e9d3-49ea-aeda-047536a27037	2024-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744
Tadalafil	TADALAFIL	Amneal Pharmaceuticals NY LLC	2cad2167-dbd1-4df8-b407-b270487d027b	2019-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209744 application number: ANDA209744

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	f2e8821e-04c9-4812-8c9e-39340775cc6e	4
484814	tadalafil 10 MG Oral Tablet	SCD	f2e8821e-04c9-4812-8c9e-39340775cc6e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-581-12	71610058112	12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-12)	2021-07-12	0000-00-00	No	No	Current