Dutasteride

Product NDC: 63629-8207
Requested package NDC: 63629-8207-3
11-digit product format: 636298207
Labeler code: 63629
Product ID: 63629-8207_b9adcc68-e71a-4805-aa88-80d2d4ddfcbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dutasteride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Bryant Ranch Prepack
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206574-001	DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB		2016-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206574-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206574-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206574-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206574-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206574-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206574-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206574-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206574-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206574-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206574-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206574-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206574-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206574-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206574-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206574-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206574-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206574-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206574-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206574-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206574-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206574-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206574-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206574-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206574-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206574-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206574-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206574-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206574-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206574-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206574-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206574-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206574-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206574-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206574-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206574-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206574-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206574-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206574-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206574-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206574-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206574-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DUTASTERIDE	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O0J6XJN02I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
170f01fe-5048-413c-b4cd-8311e1a2728a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ee39297f-c54b-4394-13fa-e0de7b5b9070	Product name	4	20250305
15cfa3ee-23c6-c9fd-f216-95d9676ee575	Product name	9	20180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-8207-1	Dutasteride	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30	7
63629-8207-2	Dutasteride	90 in 1 BOTTLE	CAPSULE, LIQUID FILLED	90	7
63629-8207-3	Dutasteride	180 in 1 BOTTLE	CAPSULE, LIQUID FILLED	180	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8207	DUTASTERIDE CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]	7	Current NDC, Legacy NDC, 3 package rows	20241004_170f01fe-5048-413c-b4cd-8311e1a2728a.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	50924a17-b21d-40ca-b702-aa61bac7af90	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	74f29982-2317-4d31-a324-fe99bd134c31	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	A-S Medication Solutions	af5e7d42-6953-4b7f-afac-257e9444b0a2	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	3285b390-f531-4e99-9bae-828ac66e874d	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals, Inc.	28519a08-3bf8-98b9-e063-6394a90a03f7	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	170f01fe-5048-413c-b4cd-8311e1a2728a	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (package): 63629-8207-3 ndc (product): 63629-8207 ndc11 (package): 63629820703
Dutasteride	DUTASTERIDE	Proficient Rx LP	908832b2-21d6-48ae-89cb-f06687321f74	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals,Inc.	85023ea5-af64-4b91-e053-2991aa0a3373	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	XLCare Pharmaceuticals, Inc.	40ddf119-b0a5-4375-9285-d50a24ed1532	2021-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	Camber Pharmaceuticals, Inc.	6b6f8d1b-1759-4fbb-9b95-c20db803e1c2	2021-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O0J6XJN02I	DUTASTERIDE	164656-23-9	DUTASTERIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351172	dutasteride 0.5 MG Oral Capsule	PSN	170f01fe-5048-413c-b4cd-8311e1a2728a	7
351172	dutasteride 0.5 MG Oral Capsule	SCD	170f01fe-5048-413c-b4cd-8311e1a2728a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8207-3	63629820703	180 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-3)	2022-04-11	0000-00-00	No	No	Current