tadalafil

Product NDC: 35573-460
11-digit product format: 355730460
Labeler code: 35573
Product ID: 35573-460_da1eee2b-ebe6-4af3-ad52-2b349a360a9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Burel Pharmaceuticals, LLC
Application: ANDA215556
Marketing category: ANDA
Marketing start: 2023-04-01
Substance: TADALAFIL
Active strength: 2.5 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A215556-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04
A215556-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04
A215556-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04
A215556-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215556-001	AB1
A215556-002	AB1
A215556-003	AB1
A215556-004	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 · 140 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	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2021-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2021-11-04	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A215556-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215556-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215556-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215556-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215556-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215556-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215556-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215556-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215556-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215556-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215556-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215556-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215556-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215556-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215556-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215556-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215556-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215556-004	AB1	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: tadalafil
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	2.5 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
a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	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	Strength	SPL version
35573-460-38	tadalafil	30 in 1 CARTON	TABLET, FILM COATED	30		4
35573-460-56	tadalafil	15 in 1 BLISTER PACK	TABLET, FILM COATED	15		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35573-460-38	EA - Each	35573-460	81bf747e-b15f-452b-8ece-319074dab7ee	1	2023-05-05
35573-460-56	EA - Each	35573-460	e5c9e3df-160f-497f-8ddd-a75c60593e75	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35573-460	TADALAFIL TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC]	3	Current NDC, 2 package rows	20230401_a2e7f393-5cfc-45e5-b87d-9e8abc8e4355.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	6c680b37-d515-4fc2-83e6-411f1017e18c	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	PD-RX Pharmaceuticals, Inc.	fc7596dd-42d3-af7c-e053-6294a90af01e	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	5de70f00-00ac-4656-883e-d1e07d5f71d6	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	A-S Medication Solutions	b2d163aa-1056-47dd-85aa-297800e6c772	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	A-S Medication Solutions	00cbc656-768d-4995-bb6d-a0d4b32a248c	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556
tadalafil	TADALAFIL	Burel Pharmaceuticals, LLC	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556 ndc (product): 35573-460
tadalafil	TADALAFIL	VKT Pharma Private Limited	b4d9851c-5c06-4532-bd82-16d92b60c28f	2021-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215556 application number: ANDA215556

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	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	4
757707	tadalafil 2.5 MG Oral Tablet	PSN	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	4
402019	tadalafil 20 MG Oral Tablet	PSN	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	4
403957	tadalafil 5 MG Oral Tablet	PSN	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	4
484814	tadalafil 10 MG Oral Tablet	SCD	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	4
757707	tadalafil 2.5 MG Oral Tablet	SCD	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	4
402019	tadalafil 20 MG Oral Tablet	SCD	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	4
403957	tadalafil 5 MG Oral Tablet	SCD	a2e7f393-5cfc-45e5-b87d-9e8abc8e4355	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
35573-460-38	35573046038	30 in 1 CARTON					Historical
35573-460-56	35573046056	15 CARTON in 1 BLISTER PACK (35573-460-56) / 30 TABLET, FILM COATED in 1 CARTON (35573-460-38)	15 carton	2023-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tadalafil	Burel Pharmaceuticals, LLC \| VKT Pharma Private Limited	2022-12-01	HUMAN PRESCRIPTION DRUG LABEL	4