Dutasteride

Product NDC
31722-131
Requested package NDC
31722-131-90
11-digit product format
317220131
Labeler code
31722
Product ID
31722-131_ea6f1af7-b293-4e0e-9559-fa6085a64c3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA206574
Marketing category
ANDA
Marketing start
2016-10-24
Substance
DUTASTERIDE
Active strength
.5 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
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 1.

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
A206574-001DUTASTERIDEDUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206574-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-213f01610625f2…
2019-09-15 20:21 UTC2019-09A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206574-001DUTASTERIDE0.5MGCAPSULE / ORALAB2016-10-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206574-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206574-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206574-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206574-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206574-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206574-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206574-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206574-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206574-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206574-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206574-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206574-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206574-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206574-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206574-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206574-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206574-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206574-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206574-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206574-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206574-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206574-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206574-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206574-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206574-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206574-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206574-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206574-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206574-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206574-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206574-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206574-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206574-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206574-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206574-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206574-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206574-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206574-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206574-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206574-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DUTASTERIDE.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351172Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6b6f8d1b-1759-4fbb-9b95-c20db803e1c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
15cfa3ee-23c6-c9fd-f216-95d9676ee575Product name920180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-131-30Dutasteride30 in 1 BOTTLECAPSULE, LIQUID FILLED305
31722-131-90Dutasteride90 in 1 BOTTLECAPSULE, LIQUID FILLED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-131-30EA - Each31722-131517e9750-c6a5-450e-a3bf-f561f9918aa212016-12-07
31722-131-90EA - Each31722-13127d961b4-82f1-4c77-8b46-128d5fee32ec12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-131DUTASTERIDE CAPSULE, LIQUID FILLED [CAMBER PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20211001_6b6f8d1b-1759-4fbb-9b95-c20db803e1c2.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DutasterideDUTASTERIDEBryant Ranch Prepack50924a17-b21d-40ca-b702-aa61bac7af902026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDEBryant Ranch Prepack74f29982-2317-4d31-a324-fe99bd134c312026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDEA-S Medication Solutionsaf5e7d42-6953-4b7f-afac-257e9444b0a22025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDEBryant Ranch Prepack3285b390-f531-4e99-9bae-828ac66e874d2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDENuCare Pharmaceuticals, Inc.28519a08-3bf8-98b9-e063-6394a90a03f72024-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDEBryant Ranch Prepack170f01fe-5048-413c-b4cd-8311e1a2728a2024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDEProficient Rx LP908832b2-21d6-48ae-89cb-f06687321f742024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDENuCare Pharmaceuticals,Inc.85023ea5-af64-4b91-e053-2991aa0a33732024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDEXLCare Pharmaceuticals, Inc.40ddf119-b0a5-4375-9285-d50a24ed15322021-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
DutasterideDUTASTERIDECamber Pharmaceuticals, Inc.6b6f8d1b-1759-4fbb-9b95-c20db803e1c22021-09-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206574
application number: ANDA206574
ndc (package): 31722-131-90
ndc (product): 31722-131
ndc11 (package): 31722013190

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351172dutasteride 0.5 MG Oral CapsulePSN74f29982-2317-4d31-a324-fe99bd134c31107
351172dutasteride 0.5 MG Oral CapsuleSCD74f29982-2317-4d31-a324-fe99bd134c31107
351172dutasteride 0.5 MG Oral CapsulePSN50924a17-b21d-40ca-b702-aa61bac7af90106
351172dutasteride 0.5 MG Oral CapsuleSCD50924a17-b21d-40ca-b702-aa61bac7af90106
351172dutasteride 0.5 MG Oral CapsulePSN3285b390-f531-4e99-9bae-828ac66e874d102
351172dutasteride 0.5 MG Oral CapsuleSCD3285b390-f531-4e99-9bae-828ac66e874d102
351172dutasteride 0.5 MG Oral CapsulePSNaf5e7d42-6953-4b7f-afac-257e9444b0a210
351172dutasteride 0.5 MG Oral CapsuleSCDaf5e7d42-6953-4b7f-afac-257e9444b0a210
351172dutasteride 0.5 MG Oral CapsulePSN170f01fe-5048-413c-b4cd-8311e1a2728a7
351172dutasteride 0.5 MG Oral CapsuleSCD170f01fe-5048-413c-b4cd-8311e1a2728a7
351172dutasteride 0.5 MG Oral CapsulePSN908832b2-21d6-48ae-89cb-f06687321f746
351172dutasteride 0.5 MG Oral CapsuleSCD908832b2-21d6-48ae-89cb-f06687321f746
351172dutasteride 0.5 MG Oral CapsulePSN6b6f8d1b-1759-4fbb-9b95-c20db803e1c25
351172dutasteride 0.5 MG Oral CapsuleSCD6b6f8d1b-1759-4fbb-9b95-c20db803e1c25
351172dutasteride 0.5 MG Oral CapsulePSN85023ea5-af64-4b91-e053-2991aa0a33734
351172dutasteride 0.5 MG Oral CapsuleSCD85023ea5-af64-4b91-e053-2991aa0a33734
351172dutasteride 0.5 MG Oral CapsulePSN28519a08-3bf8-98b9-e063-6394a90a03f71
351172dutasteride 0.5 MG Oral CapsulePSNd4c90e01-1c61-6865-e053-2995a90ae6dd1
351172dutasteride 0.5 MG Oral CapsuleSCD28519a08-3bf8-98b9-e063-6394a90a03f71
351172dutasteride 0.5 MG Oral CapsuleSCDd4c90e01-1c61-6865-e053-2995a90ae6dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-131-903172201319090 CAPSULE, LIQUID FILLED in 1 BOTTLE (31722-131-90) 2016-11-070000-00-00NoNoCurrent