Tadalafil

Product NDC: 69097-375
11-digit product format: 690970375
Labeler code: 69097
Product ID: 69097-375_92ec5f3d-f54d-4f28-bac6-b606c99b17c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA209539
Marketing category: ANDA
Marketing start: 2019-03-26
Marketing end: 0000-00-00
Substance: TADALAFIL
Active strength: 10 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69097-375		D	Discontinued by firm	2026-10-12
excluded package	package	69097-375	69097-375-02	D	Discontinued by firm	2026-10-12
excluded package	package	69097-375	69097-375-05	D	Discontinued by firm	2026-10-12
excluded package	package	69097-375	69097-375-15	D	Discontinued by firm	2026-10-12

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209539-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209539-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209539-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26
A209539-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209539-001	AB1
A209539-002	AB1
A209539-003	AB1
A209539-004	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 5 · 172 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	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209539-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209539-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209539-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209539-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209539-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209539-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209539-003	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209539-004	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209539-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209539-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209539-003	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209539-004	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209539-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209539-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209539-003	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209539-004	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209539-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209539-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209539-003	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209539-004	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209539-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209539-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209539-003	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209539-004	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209539-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209539-002	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209539-003	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209539-004	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209539-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209539-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209539-003	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209539-004	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209539-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209539-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209539-003	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209539-004	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209539-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209539-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209539-003	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209539-004	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209539-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209539-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209539-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209539-004	AB1	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-375-02	EA - Each	69097-375	c7c43546-d82c-4105-84ac-5feefadf5125	1	2019-04-11
69097-375-05	EA - Each	69097-375	6c30c01c-893b-4ebf-a708-73a7c0ecec5c	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-375	TADALAFIL TABLET, FILM COATED [CIPLA USA INC.]	7	Legacy NDC	20221226_07fc5cfc-86c9-46b9-ad5a-8d8638a3fc42.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
742SXX0ICT	TADALAFIL	171596-29-5	TADALAFIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-375-02	69097037502	30 TABLET, FILM COATED in 1 BOTTLE (69097-375-02)	2019-03-26	0000-00-00	No	No	Current
69097-375-05	69097037505	90 TABLET, FILM COATED in 1 BOTTLE (69097-375-05)	2019-03-26	0000-00-00	No	No	Current
69097-375-15	69097037515	1000 TABLET, FILM COATED in 1 BOTTLE (69097-375-15)	2019-03-26	0000-00-00	No	No	Current