Tadalafil

Product NDC: 63629-7943
Requested package NDC: 63629-7943-2
11-digit product format: 636297943
Labeler code: 63629
Product ID: 63629-7943_63a6ae33-49d7-41f8-9974-d8d805812118
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA210255
Marketing category: ANDA
Marketing start: 2019-02-05
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#

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	63629-7943	63629-7943-2	I	Inactivated by FDA		2026-10-05

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 43.

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
A210255-001	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB2		2019-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210255-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210255-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210255-001	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210255-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210255-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210255-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210255-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210255-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210255-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210255-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210255-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210255-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210255-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210255-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210255-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210255-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210255-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210255-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210255-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210255-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210255-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210255-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210255-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210255-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210255-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210255-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210255-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210255-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210255-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210255-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210255-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210255-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210255-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210255-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210255-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210255-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210255-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210255-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210255-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210255-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210255-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210255-001	AB2	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
63629-7943-1	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003
63629-7943-2	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003
63629-7943-3	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003
63629-7943-4	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003
63629-7943-5	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003
63629-7943-6	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003
63629-7943-7	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-7943-1	Tadalafil	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
63629-7943-2	Tadalafil	10 in 1 BOTTLE	TABLET, FILM COATED	10	8
63629-7943-3	Tadalafil	90 in 1 BOTTLE	TABLET, FILM COATED	90	8
63629-7943-4	Tadalafil	5 in 1 BOTTLE	TABLET, FILM COATED	5	8
63629-7943-5	Tadalafil	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
63629-7943-6	Tadalafil	20 in 1 BOTTLE	TABLET, FILM COATED	20	8
63629-7943-7	Tadalafil	15 in 1 BOTTLE	TABLET, FILM COATED	15	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-7943	TADALAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]	8	Legacy NDC, 7 package rows	20220118_63a6ae33-49d7-41f8-9974-d8d805812118.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
Tadalafil	TADALAFIL	Cipla USA Inc.	cf6fc925-ad20-4ed0-9356-15d24afa8d0b	2020-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210255 application number: ANDA210255

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
2123194	tadalafil 20 MG Pulmonary Hypertension Oral Tablet	PSN	63a6ae33-49d7-41f8-9974-d8d805812118	8
2123194	Pulmonary Hypertension tadalafil 20 MG Oral Tablet	SCD	63a6ae33-49d7-41f8-9974-d8d805812118	8
2123194	tadalafil 20 MG Pulmonary Hypertension Oral Tablet	SY	63a6ae33-49d7-41f8-9974-d8d805812118	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7943-2	63629794302	10 TABLET, FILM COATED in 1 BOTTLE (63629-7943-2)	2019-03-12	0000-00-00	No	No	Current