TADALAFIL

Product NDC: 43547-049
Requested package NDC: 43547-049-03
11-digit product format: 435470049
Labeler code: 43547
Product ID: 43547-049_b7c42c71-e6fa-4e5d-afe3-617dc236a69f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tadalafil
Dosage form: TABLET
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA210609
Marketing category: ANDA
Marketing start: 2022-01-18
Substance: TADALAFIL
Active strength: 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 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
A210609-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11
A210609-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11
A210609-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11
A210609-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210609-001	AB1
A210609-002	AB1
A210609-003	AB1
A210609-004	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	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`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	A210609-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A210609-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A210609-003	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A210609-004	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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TADALAFIL	TADALAFIL	REMEDYREPACK INC.	89a33a41-0f01-4f29-8b2f-769d649fbdcb	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	Bryant Ranch Prepack	b3a58c17-f260-4125-abd1-27da00bb0719	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals,Inc..	16f13179-7c87-aa6c-e063-6294a90a93eb	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	351e28ca-3ae6-e535-e063-6394a90a9fb7	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	A-S Medication Solutions	cd94158b-43fa-44fc-a858-0983770efa83	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	Preferred Pharmaceuticals Inc.	66e24ced-0008-40cb-b242-9d9add1f665c	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	Preferred Pharmaceuticals Inc.	09ad27a1-3908-4533-b84c-7a7fd3514101	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	Solco Healthcare US, LLC	05640a4d-afb7-42ae-a5bb-77dbc8412356	2025-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609 ndc (package): 43547-049-03 ndc (product): 43547-049 ndc11 (package): 43547004903
TADALAFIL	TADALAFIL	Bryant Ranch Prepack	716c586d-e524-4f3e-ab1d-7ef9184169d9	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	351de7c2-98bf-7c88-e063-6294a90ad811	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	Aphena Pharma Solutions - Tennessee, LLC	34684fe8-9bf3-47fd-e063-6394a90ac80f	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals, Inc.	2c4108c6-9014-4bd8-e063-6294a90a88fa	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	Solco Healthcare US, LLC	491cb72b-71f2-4df9-99f8-c02d93500103	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals, Inc.	2eae8756-5c7f-2545-e063-6294a90a6d52	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals,Inc.	0b75f746-866e-3a5b-e063-6294a90a5e02	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals, Inc.	2ad52dff-9fcd-041f-e063-6394a90afcef	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals,Inc.	2a4666e1-4151-f540-e063-6394a90aed0b	2024-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609
TADALAFIL	TADALAFIL	NuCare Pharmaceuticals,Inc.	17947ccd-6f0e-d4cd-e063-6294a90a108a	2024-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210609 application number: ANDA210609

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	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
05640a4d-afb7-42ae-a5bb-77dbc8412356	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43547-049-03	TADALAFIL	30 in 1 BOTTLE	TABLET	30	6
43547-049-11	TADALAFIL	1000 in 1 BOTTLE	TABLET	1000	6
43547-049-50	TADALAFIL	500 in 1 BOTTLE	TABLET	500	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-049-03	EA - Each	43547-049	b89e62ab-ea53-4e71-bf32-3c58a63c64bb	1	2022-12-07
43547-049-50	EA - Each	43547-049	f5bdd6db-8d95-47c5-b56d-cad30c1a966e	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-049	TADALAFIL TABLET [SOLCO HEALTHCARE US, LLC]	2	Current NDC, Legacy NDC, 3 package rows	20230908_05640a4d-afb7-42ae-a5bb-77dbc8412356.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
484814	tadalafil 10 MG Oral Tablet	PSN	05640a4d-afb7-42ae-a5bb-77dbc8412356	6
757707	tadalafil 2.5 MG Oral Tablet	PSN	05640a4d-afb7-42ae-a5bb-77dbc8412356	6
402019	tadalafil 20 MG Oral Tablet	PSN	05640a4d-afb7-42ae-a5bb-77dbc8412356	6
403957	tadalafil 5 MG Oral Tablet	PSN	05640a4d-afb7-42ae-a5bb-77dbc8412356	6
484814	tadalafil 10 MG Oral Tablet	SCD	05640a4d-afb7-42ae-a5bb-77dbc8412356	6
757707	tadalafil 2.5 MG Oral Tablet	SCD	05640a4d-afb7-42ae-a5bb-77dbc8412356	6
402019	tadalafil 20 MG Oral Tablet	SCD	05640a4d-afb7-42ae-a5bb-77dbc8412356	6
403957	tadalafil 5 MG Oral Tablet	SCD	05640a4d-afb7-42ae-a5bb-77dbc8412356	6
403957	tadalafil 5 MG Oral Tablet	PSN	66e24ced-0008-40cb-b242-9d9add1f665c	3
403957	tadalafil 5 MG Oral Tablet	PSN	89a33a41-0f01-4f29-8b2f-769d649fbdcb	3
403957	tadalafil 5 MG Oral Tablet	SCD	66e24ced-0008-40cb-b242-9d9add1f665c	3
403957	tadalafil 5 MG Oral Tablet	SCD	89a33a41-0f01-4f29-8b2f-769d649fbdcb	3
403957	tadalafil 5 MG Oral Tablet	PSN	0b75f746-866e-3a5b-e063-6294a90a5e02	2
403957	tadalafil 5 MG Oral Tablet	PSN	16f13179-7c87-aa6c-e063-6294a90a93eb	2
403957	tadalafil 5 MG Oral Tablet	SCD	0b75f746-866e-3a5b-e063-6294a90a5e02	2
403957	tadalafil 5 MG Oral Tablet	SCD	16f13179-7c87-aa6c-e063-6294a90a93eb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-049-03	43547004903	30 TABLET in 1 BOTTLE (43547-049-03)	30 tablet	2022-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TADALAFIL	REMEDYREPACK INC.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	4
TADALAFIL	NuCare Pharmaceuticals,Inc.. \| NuCare Pharmaceuticals,Inc.	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	3
TADALAFIL	Preferred Pharmaceuticals Inc.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	3
TADALAFIL	Solco Healthcare US, LLC \| Prinston Pharmaceutical Inc. \| Zhejiang Huahai Pharmaceutical Co., LTD \| Zhejiang Huahai Pharmaceutical Technology Co., Ltd.	2025-08-31	HUMAN PRESCRIPTION DRUG LABEL	6
TADALAFIL	NuCare Pharmaceuticals,Inc.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	2