Tadalafil

Product NDC: 50436-0370
Requested package NDC: 50436-0370-1
11-digit product format: 504360370
Labeler code: 50436
Product ID: 50436-0370_6a89c13d-8ba2-491f-a3a7-432a9967b6b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA209167
Marketing category: ANDA
Marketing start: 2019-03-27
Marketing end: 0000-00-00
Substance: TADALAFIL
Active strength: 5 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50436-0370	50436-0370-1	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
A209167-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209167-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209167-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23
A209167-004	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
A209167-001	AB1
A209167-002	AB1
A209167-003	AB1
A209167-004	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	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209167-004	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	A209167-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209167-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209167-003	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209167-004	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	Bryant Ranch Prepack	07567ae5-7345-4ab1-9b2c-c586c4da0427	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Bryant Ranch Prepack	aa8d165b-0c7d-497a-b56a-7c62ebc0a5d2	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Bryant Ranch Prepack	f8def23c-55ea-4796-9735-dbcb25104835	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Accord Healthcare Inc.	eedf3ad9-7d40-496d-b1a9-6200010c18e1	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	affacb88-4af3-4ce9-961b-7fc37b169e9a	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f3092f5a-b976-91ab-e053-2995a90a9b50	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f317fe1e-d7c4-fb8b-e053-2a95a90a5445	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf35291b-b05b-1182-e053-2995a90a8dee	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	9f83ea2e-8ee8-ab6d-e053-2995a90a1e96	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	a0acad71-8ae3-2827-e053-2995a90a20b3	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	7a105ef9-7129-4ce1-bd8d-ae316bf348e2	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	b539e862-d5d4-4989-a3dd-1eba66285d53	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	31c05a53-7282-46d0-81bd-108defe6fb38	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	6fa9d4fa-86c9-4791-b28b-78e8b9341cea	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Asclemed USA, Inc.	aba646fe-70c2-1abb-e053-2995a90aa16d	2022-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167

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
50436-0370-1	2024-01-30	C162847	48780-1	1030e365-417a-111a-e063-dadaa90a10e2	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
50436-0370-2	2024-01-30	C162847	48780-1	1030e365-417a-111a-e063-dadaa90a10e2	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
50436-0370-1	Tadalafil	30 in 1 BOTTLE	TABLET, FILM COATED	30		4
50436-0370-2	Tadalafil	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0370	TADALAFIL TABLET, FILM COATED [UNIT DOSE SERVICES]	4	Legacy NDC, 2 package rows	20220922_e3aafacc-c392-4a0c-82ed-ef139e363732.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
403957	tadalafil 5 MG Oral Tablet	PSN	e3aafacc-c392-4a0c-82ed-ef139e363732	4
403957	tadalafil 5 MG Oral Tablet	SCD	e3aafacc-c392-4a0c-82ed-ef139e363732	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-0370-1	50436037001	30 TABLET, FILM COATED in 1 BOTTLE (50436-0370-1)	2021-11-01	0000-00-00	No	No	Current