TADALAFIL

Product NDC: 43547-051
Requested package NDC: 43547-051-11
11-digit product format: 435470051
Labeler code: 43547
Product ID: 43547-051_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: 20 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.

Product history page 1 of 3 · 108 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
2026-02-19 14:30 UTC	2026-02	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210609-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2022-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210609-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2022-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210609-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2022-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210609-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2022-08-11	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210609-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210609-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210609-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210609-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210609-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210609-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210609-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210609-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210609-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210609-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210609-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210609-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210609-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210609-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210609-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210609-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210609-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210609-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210609-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210609-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210609-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210609-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210609-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210609-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210609-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210609-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210609-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210609-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210609-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210609-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210609-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210609-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210609-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210609-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210609-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210609-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210609-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210609-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210609-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210609-004	AB1	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	20 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
43547-051-03	TADALAFIL	30 in 1 BOTTLE	TABLET	30	6
43547-051-11	TADALAFIL	1000 in 1 BOTTLE	TABLET	1000	6
43547-051-50	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
43547-051-03	EA - Each	43547-051	fc03c5a1-3e03-42de-9c7a-836c29f164f4	1	2022-12-07
43547-051-50	EA - Each	43547-051	de9bc864-3327-4b28-991f-45caeb0cb0f4	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-051	TADALAFIL TABLET [SOLCO HEALTHCARE US, LLC]	2	Current NDC, Legacy NDC, 3 package rows	20230908_05640a4d-afb7-42ae-a5bb-77dbc8412356.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 · 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): 43547-051-11 ndc (product): 43547-051 ndc11 (package): 43547005111
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

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
402019	tadalafil 20 MG Oral Tablet	PSN	cd94158b-43fa-44fc-a858-0983770efa83	4
402019	tadalafil 20 MG Oral Tablet	SCD	cd94158b-43fa-44fc-a858-0983770efa83	4
402019	tadalafil 20 MG Oral Tablet	PSN	09ad27a1-3908-4533-b84c-7a7fd3514101	2
402019	tadalafil 20 MG Oral Tablet	PSN	2c4108c6-9014-4bd8-e063-6294a90a88fa	2
402019	tadalafil 20 MG Oral Tablet	SCD	09ad27a1-3908-4533-b84c-7a7fd3514101	2
402019	tadalafil 20 MG Oral Tablet	SCD	2c4108c6-9014-4bd8-e063-6294a90a88fa	2
402019	tadalafil 20 MG Oral Tablet	PSN	2a4666e1-4151-f540-e063-6394a90aed0b	1
402019	tadalafil 20 MG Oral Tablet	SCD	2a4666e1-4151-f540-e063-6394a90aed0b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
43547-051-11	43547005111	1000 TABLET in 1 BOTTLE (43547-051-11)	1000 tablet	2022-01-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TADALAFIL	A-S Medication Solutions	2026-02-02	HUMAN PRESCRIPTION DRUG LABEL	4
TADALAFIL	Preferred Pharmaceuticals Inc.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	2
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.	2025-04-09	HUMAN PRESCRIPTION DRUG LABEL	2
TADALAFIL	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceuticals, Inc.	2024-12-27	HUMAN PRESCRIPTION DRUG LABEL	1