FDA.reportPublic FDA data

Dutasteride and tamsulosin hydrochloride

Product NDC
68382-640
11-digit product format
683820640
Labeler code
68382
Product ID
68382-640_9e44a416-1d3d-418c-a113-f6c65175b564
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride and tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
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-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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A207769-001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE0.5MG;0.4MGCAPSULE / ORALAB2018-05-24e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A207769-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Dutasteride and tamsulosin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O0J6XJN02IInternal UNII lookup
11SV1951MRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996097Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6557691-7910-4006-9268-410583e437d1Available on FDA.report

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-640-06Dutasteride and tamsulosin hydrochloride30 in 1 BOTTLECAPSULE305
68382-640-16Dutasteride and tamsulosin hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-640-06EA - Each68382-6406284ec7a-7fb8-4e75-8d46-47a7cd45b21912018-07-03
68382-640-16EA - Each68382-640174a36c5-9258-4cf8-a1b9-fd0fdea7fa1512018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-640DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20241113_d6557691-7910-4006-9268-410583e437d1.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 · 2 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
application applno (ANDA): 207769
application number: ANDA207769
Dutasteride and tamsulosin hydrochlorideDUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.d6557691-7910-4006-9268-410583e437d12024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207769
application number: ANDA207769
ndc (product): 68382-640

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996097dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral CapsulePSNd6557691-7910-4006-9268-410583e437d15
996097dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDd6557691-7910-4006-9268-410583e437d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-640-066838206400630 CAPSULE in 1 BOTTLE (68382-640-06) 30 capsule2018-06-040000-00-00NoNoCurrent
68382-640-166838206401690 CAPSULE in 1 BOTTLE (68382-640-16) 90 capsule2018-06-040000-00-00NoNoCurrent