Dutasteride

Product NDC: 53345-037
11-digit product format: 533450037
Labeler code: 53345
Product ID: 53345-037_b5d3028b-d3d8-40b8-b013-9a7e99c3eaef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dutasteride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application: ANDA209909
Marketing category: ANDA
Marketing start: 2018-04-25
Marketing end: 0000-00-00
Substance: DUTASTERIDE
Active strength: 1 mg/1
Pharmacologic classes: 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53345-037		I	Inactivated by FDA		2026-08-17
excluded package	package	53345-037	53345-037-01	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53345-037-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53345-037-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53345-037-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53345-037-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53345-037-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53345-037-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53345-037-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53345-037-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53345-037-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209909-001	DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB		2017-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209909-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209909-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2017-11-21	`e64feba35796…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209909-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209909-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209909-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209909-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209909-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209909-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209909-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209909-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209909-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209909-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209909-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209909-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209909-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209909-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209909-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209909-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209909-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209909-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209909-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209909-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209909-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209909-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209909-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209909-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209909-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209909-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209909-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209909-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209909-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209909-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209909-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209909-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209909-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209909-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209909-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209909-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209909-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209909-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209909-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209909-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53345-037-01	2025-01-30	C162847	48780-1	2cef2736-805d-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES . DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53345-037-01	Dutasteride	12000 in 1 BAG	CAPSULE, LIQUID FILLED	12000		1
53345-037-01	Dutasteride	1 in 1 BOX	CAPSULE, LIQUID FILLED	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53345-037	DUTASTERIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]	1	Legacy NDC, 2 package rows	20180426_cf1cbcbf-f466-4caf-9ba1-2faccdc2a3cf.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dutasteride	DUTASTERIDE	A-S Medication Solutions	af338f55-55c1-4034-9c27-c3564addf24e	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209909 application number: ANDA209909
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals, Inc.	369f73b9-e032-4315-e063-6294a90a4ca1	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209909 application number: ANDA209909
Dutasteride	DUTASTERIDE	Epic Pharma, LLC	2ee1eef5-8ec7-46c1-b4fa-13184915448f	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209909 application number: ANDA209909
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals, Inc.	2ad309b1-4497-8b9b-e063-6394a90aa9b4	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209909 application number: ANDA209909

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	cf1cbcbf-f466-4caf-9ba1-2faccdc2a3cf	1
351172	dutasteride 0.5 MG Oral Capsule	SCD	cf1cbcbf-f466-4caf-9ba1-2faccdc2a3cf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53345-037-01	53345003701	1 BAG in 1 BOX (53345-037-01) > 12000 CAPSULE, LIQUID FILLED in 1 BAG	1 bag	2018-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dutasteride	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. \| Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd	2018-04-25	HUMAN PRESCRIPTION DRUG LABEL	1