Tadalafil

Product NDC: 68071-2632
11-digit product format: 680712632
Labeler code: 68071
Product ID: 68071-2632_d6e8c52f-4dc2-5d54-e053-2995a90a9358
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA209654
Marketing category: ANDA
Marketing start: 2019-03-26
Marketing end: 0000-00-00
Substance: TADALAFIL
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2632		I	Inactivated by FDA		2026-07-31
excluded package	package	68071-2632	68071-2632-3	I	Inactivated by FDA		2026-07-31

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
A209654-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209654-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209654-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A209654-004	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
A209654-001	AB1
A209654-002	AB1
A209654-003	AB1
A209654-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A209654-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A209654-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-003	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209654-004	AB1	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	REMEDYREPACK INC.	415bd983-86f3-4f38-917a-9805024f31cb	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	REMEDYREPACK INC.	ad288e9d-020a-43a0-9c07-320c5c3bbc1e	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	2c2ec257-06bc-4ca4-9cf3-d0f49980e374	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	c835a34a-9bae-4d88-b951-1b78ab92f388	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	f34e4747-28be-4ae5-ac9a-a825083b6a9b	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	PD-Rx Pharmaceuticals, Inc.	7e236f83-14bf-4862-91fb-74d766aef6a9	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf353da9-31c6-66c2-e053-2995a90a3bb0	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Quallent Pharmaceuticals Health LLC	dc14daa3-cae9-4751-9034-b0e9c18054b4	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Ajanta Pharma USA Inc.	7e4cdac1-42cc-4038-a86b-4890962ed806	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f8	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	761dc0f8-2f65-4615-ab49-a4bcffd40ce9	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
TADALAFIL	TADALAFIL	direct rx	b3ee8325-bcb2-43fd-e053-2a95a90a08c8	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	0a9cf85a-c17d-6890-e063-6394a90a93e9	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	85ed0cbc-df84-44df-a9eb-f9587dbc21df	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Bryant Ranch Prepack	185a3284-3a4f-44d3-9278-98581d33f95b	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	A-S Medication Solutions	b1840f16-a7ea-44bd-b091-5268990aedb2	2024-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	6213fd38-9580-4253-91d2-14c28a711c20	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Asclemed USA, Inc.	5ea24573-2d16-40d8-a46c-7b5fa8669e69	2023-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Proficient Rx LP	aa345972-40b4-415e-acb5-31b808a8d815	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654
Tadalafil	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	36350106-98bc-41fc-bede-8be5e6f54a8a	2020-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209654 application number: ANDA209654

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2632-3	2025-01-30	C162847	48780-1	2cef2736-9449-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2632-3	Tadalafil	30 in 1 BOTTLE	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2632	TADALAFIL TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220201_d6e8c52f-4dc3-5d54-e053-2995a90a9358.zip

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
402019	tadalafil 20 MG Oral Tablet	PSN	d6e8c52f-4dc3-5d54-e053-2995a90a9358	1
402019	tadalafil 20 MG Oral Tablet	SCD	d6e8c52f-4dc3-5d54-e053-2995a90a9358	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2632-3	68071263203	30 TABLET in 1 BOTTLE (68071-2632-3)	30 tablet	2022-01-31	0000-00-00	No	No	Current