Dutasteride and tamsulosin hydrochloride

Product NDC: 70771-1356
Requested package NDC: 70771-1356-9
11-digit product format: 707711356
Labeler code: 70771
Product ID: 70771-1356_cdb5801c-8313-41cc-908e-24441940f578
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dutasteride and tamsulosin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA207769
Marketing category: ANDA
Marketing start: 2018-06-04
Substance: DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Active strength: .5; .4 mg/1; mg/1
Pharmacologic classes: 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
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 44.

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
A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	RS	2018-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207769-001	AB

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 · 44 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
2026-10-15 13:18:30	2026-09	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	RS	2018-05-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	RS	2018-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	RS	2018-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	RS	2018-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	RS	2018-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207769-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB		2018-05-24	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207769-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207769-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207769-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207769-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207769-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207769-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207769-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207769-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207769-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207769-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207769-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207769-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207769-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207769-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207769-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207769-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207769-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207769-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207769-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207769-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207769-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207769-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207769-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207769-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207769-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207769-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207769-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207769-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207769-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207769-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207769-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207769-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207769-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207769-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207769-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207769-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207769-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207769-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207769-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207769-001	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Dutasteride and tamsulosin hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DUTASTERIDE	.5 mg/1
TAMSULOSIN HYDROCHLORIDE	.4 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
ee39297f-c54b-4394-13fa-e0de7b5b9070	Product name	4	20250305
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
ae349df8-97ce-a639-ed32-50a4cb01b1bd	Product name	4	20200313
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
15cfa3ee-23c6-c9fd-f216-95d9676ee575	Product name	9	20180814
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70771-1356-3	Dutasteride and tamsulosin hydrochloride	30 in 1 BOTTLE	CAPSULE	30		6
70771-1356-9	Dutasteride and tamsulosin hydrochloride	90 in 1 BOTTLE	CAPSULE	90		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1356	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20241201_4b89b07e-9d19-47a2-bd53-bc5eef9deed1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O0J6XJN02I	DUTASTERIDE	164656-23-9	DUTASTERIDE
11SV1951MR	TAMSULOSIN HYDROCHLORIDE	106463-17-6	TAMSULOSIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996097	dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral Capsule	PSN	4b89b07e-9d19-47a2-bd53-bc5eef9deed1	6
996097	dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule	SCD	4b89b07e-9d19-47a2-bd53-bc5eef9deed1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1356-9	70771135609	90 CAPSULE in 1 BOTTLE (70771-1356-9)	90 capsule	2018-06-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES	Zydus Lifesciences Limited	2026-10-05	HUMAN PRESCRIPTION DRUG LABEL	7