FDA.reportPublic FDA data

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-10-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-09 01:03:55

Label at a glance#

ProductDutasteride and tamsulosin hydrochloride
Active ingredientDUTASTERIDE, TAMSULOSIN HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1356-3

Dutasteride and tamsulosin hydrochloride capsules USP, 0.4/0.5 mg

Rx only

30 Capsules

Dutasteride and tamsulosin hydrochloride capsules
Dutasteride and tamsulosin hydrochloride capsules

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-135670771-1356-3, 70771-1356-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
DUTASTERIDEO0J6XJN02IACTIB
TAMSULOSIN HYDROCHLORIDE11SV1951MRACTIB
ALCOHOL3K9958V90MIACT
AMMONIA5138Q19F1XIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CARRAGEENAN5C69YCD2YJIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONO- AND DICAPRYLOCAPRATEU72Q2I8C85IACT
HYPROMELLOSES3NXW29V3WOIACT
ISOPROPYL ALCOHOLND2M416302IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERNX76LV5T8JIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM CHLORIDE660YQ98I10IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-28full-release2026-05-31 21:18:23

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEDUTASTERIDE; TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALABRS2018-05-24

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALABRS2018-05-2484e616aacf4f…
2026-08-18 06:07:402026-07A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALABRS2018-05-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALABRS2018-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALABRS2018-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-243f01610625f2…
2019-09-15 20:21 UTC2019-09A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24f41ea6bd6efb…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207769-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A207769-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207769-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207769-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207769-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207769-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207769-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207769-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207769-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207769-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207769-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207769-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207769-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207769-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207769-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207769-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207769-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207769-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207769-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207769-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207769-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207769-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207769-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207769-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207769-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207769-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207769-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207769-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207769-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207769-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207769-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207769-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207769-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207769-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207769-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207769-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207769-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207769-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207769-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207769-001AB1f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dutasteride and tamsulosin hydrochlorideDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEZydus Lifesciences Limited4b89b07e-9d19-47a2-bd53-bc5eef9deed12024-11-28Exact identifier
ndc (package): 70771-1356-3
ndc (package): 70771-1356-9
ndc (product): 70771-1356
ndc11 (package): 70771135603
ndc11 (package): 70771135609
spl set id: 4b89b07e-9d19-47a2-bd53-bc5eef9deed1

Reported adverse events (FAERS/openFDA)#

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