ADCIRCA

Product NDC: 43353-070
Requested package NDC: 43353-070-12
11-digit product format: 433530070
Labeler code: 43353
Product ID: 43353-070_f3f54d01-32f6-46ed-84be-4f31cb8c556e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA022332
Marketing category: NDA
Marketing start: 2009-05-22
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	43353-070	43353-070-12	I	Inactivated by FDA		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022332-001	ADCIRCA	TADALAFIL	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022332-001	AB2

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022332-001	ADCIRCA	20MG	TABLET / ORAL	AB2	RLD, RS	2009-05-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022332-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022332-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022332-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022332-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022332-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022332-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022332-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022332-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022332-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022332-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022332-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022332-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022332-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022332-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022332-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022332-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022332-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022332-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022332-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022332-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022332-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022332-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022332-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022332-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022332-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022332-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022332-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022332-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022332-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022332-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022332-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022332-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022332-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022332-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022332-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022332-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022332-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022332-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022332-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022332-001	AB2	1	`e64feba35796…`

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
43353-070-12	2023-01-30	C162847	48780-1	f386c64a-2b93-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ADCIRCA safely and effectively. See full prescribing information for ADCIRCA. ADCIRCA (tadalafil) tablets for oral administration Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-070-12	ADCIRCA	12 in 1 BOTTLE	TABLET	12		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-070-12	EA - Each	43353-070	3dea25b0-2247-4b70-884c-c9f27eb8117a	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-070	ADCIRCA (TADALAFIL) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 1 package rows	20191220_3ca3928a-6466-4290-a228-461fa8a91735.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADCIRCA	TADALAFIL	United Therapeutics Corporation	ff61b237-be8e-461b-8114-78c52a8ad0ae	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022332 application number: NDA022332

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
849866	adcirca 20 MG Oral Tablet	PSN	3ca3928a-6466-4290-a228-461fa8a91735	3
2123194	tadalafil 20 MG Pulmonary Hypertension Oral Tablet	PSN	3ca3928a-6466-4290-a228-461fa8a91735	3
849866	Pulmonary Hypertension tadalafil 20 MG Oral Tablet [Adcirca]	SBD	3ca3928a-6466-4290-a228-461fa8a91735	3
2123194	Pulmonary Hypertension tadalafil 20 MG Oral Tablet	SCD	3ca3928a-6466-4290-a228-461fa8a91735	3
849866	Adcirca 20 MG Oral Tablet	SY	3ca3928a-6466-4290-a228-461fa8a91735	3
849866	Adcirca 20 MG Pulmonary Hypertension Oral Tablet	SY	3ca3928a-6466-4290-a228-461fa8a91735	3
2123194	tadalafil 20 MG Pulmonary Hypertension Oral Tablet	SY	3ca3928a-6466-4290-a228-461fa8a91735	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-070-12	43353007012	12 TABLET in 1 BOTTLE (43353-070-12)	12 tablet	2017-06-22	0000-00-00	No	No	Current