ADCIRCA

Product NDC: 66302-467
11-digit product format: 663020467
Labeler code: 66302
Product ID: 66302-467_76c30323-0981-499c-b552-1a43f01c89c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET
Route: ORAL
Labeler: United Therapeutics Corporation
Application: NDA022332
Marketing category: NDA
Marketing start: 2009-05-22
Substance: TADALAFIL
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ADCIRCA
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849866	Internal RxNorm lookup
2123194	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
ff61b237-be8e-461b-8114-78c52a8ad0ae	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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66302-467-60	ADCIRCA	60 in 1 BOTTLE	TABLET	60		34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66302-467-60	EA - Each	66302-467	e3cc09c6-f3cc-4e3d-9112-4d5192977420	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
tadalafil	ACTIVE MOIETY	742SXX0ICT	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Hydroxypropyl cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66302-467	ADCIRCA (TADALAFIL) TABLET [UNITED THERAPEUTICS CORPORATION]	33	Current NDC, Legacy NDC, 1 package rows	20241215_ff61b237-be8e-461b-8114-78c52a8ad0ae.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 ndc (product): 66302-467

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	ff61b237-be8e-461b-8114-78c52a8ad0ae	34
2123194	tadalafil 20 MG Pulmonary Hypertension Oral Tablet	PSN	ff61b237-be8e-461b-8114-78c52a8ad0ae	34
849866	Pulmonary Hypertension tadalafil 20 MG Oral Tablet [Adcirca]	SBD	ff61b237-be8e-461b-8114-78c52a8ad0ae	34
2123194	Pulmonary Hypertension tadalafil 20 MG Oral Tablet	SCD	ff61b237-be8e-461b-8114-78c52a8ad0ae	34
849866	Adcirca 20 MG Oral Tablet	SY	ff61b237-be8e-461b-8114-78c52a8ad0ae	34
849866	Adcirca 20 MG Pulmonary Hypertension Oral Tablet	SY	ff61b237-be8e-461b-8114-78c52a8ad0ae	34
2123194	tadalafil 20 MG Pulmonary Hypertension Oral Tablet	SY	ff61b237-be8e-461b-8114-78c52a8ad0ae	34
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
66302-467-60	66302046760	60 TABLET in 1 BOTTLE (66302-467-60)	60 tablet	2009-08-03	0000-00-00	No	No	Current
66302-467-61	66302046761	14 TABLET in 1 BOTTLE (66302-467-61)	14 tablet	2011-05-11	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADCIRCA	United Therapeutics Corporation \| Eli Lilly and Company	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	34
ADCIRCA	Aphena Pharma Solutions - Tennessee, LLC	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	3