Tadalafil

Product NDC: 50090-6150
Requested package NDC: 50090-6150-0
11-digit product format: 500906150
Labeler code: 50090
Product ID: 50090-6150_bb96d614-7c9d-4d67-b6db-56f1ff64d9da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA209167
Marketing category: ANDA
Marketing start: 2019-03-27
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-6150	50090-6150-0	D	Discontinued by firm		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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6150-0	EA - Each	50090-6150	4b33261c-1bf0-45e5-b53a-6304e0ff489e	1	2022-11-07
50090-6150-1	EA - Each	50090-6150	6991fc0c-8a34-4ee1-b37c-bec3a037d6a1	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6150	TADALAFIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	4	Legacy NDC	20240110_a6847ad6-3b5b-47e5-a3b5-04dc3182d72b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
742SXX0ICT	TADALAFIL	171596-29-5	TADALAFIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-6150-0	50090615000	30 TABLET, FILM COATED in 1 BOTTLE (50090-6150-0)	2022-10-05	0000-00-00	No	No	Current