Dutasteride

Product NDC: 42806-549
11-digit product format: 428060549
Labeler code: 42806
Product ID: 42806-549_2b367985-feb6-bf97-e063-6294a90aede5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dutasteride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Epic Pharma, LLC
Application: ANDA209909
Marketing category: ANDA
Marketing start: 2017-11-28
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 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…`

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
2ee1eef5-8ec7-46c1-b4fa-13184915448f	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
15cfa3ee-23c6-c9fd-f216-95d9676ee575	Product name	9	20180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42806-549-09	Dutasteride	90 in 1 BOTTLE	CAPSULE, LIQUID FILLED	90		3
42806-549-30	Dutasteride	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42806-549-09	EA - Each	42806-549	ad5e8604-7b1a-444e-a67e-c69b50485502	1	2018-03-08
42806-549-30	EA - Each	42806-549	c0ef0504-befd-4726-8f38-670f28f1cbb4	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-549	DUTASTERIDE CAPSULE, LIQUID FILLED [EPIC PHARMA, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20250110_2ee1eef5-8ec7-46c1-b4fa-13184915448f.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 ndc (product): 42806-549
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	2ee1eef5-8ec7-46c1-b4fa-13184915448f	3
351172	dutasteride 0.5 MG Oral Capsule	PSN	af338f55-55c1-4034-9c27-c3564addf24e	3
351172	dutasteride 0.5 MG Oral Capsule	SCD	2ee1eef5-8ec7-46c1-b4fa-13184915448f	3
351172	dutasteride 0.5 MG Oral Capsule	SCD	af338f55-55c1-4034-9c27-c3564addf24e	3
351172	dutasteride 0.5 MG Oral Capsule	PSN	2ad309b1-4497-8b9b-e063-6394a90aa9b4	1
351172	dutasteride 0.5 MG Oral Capsule	PSN	369f73b9-e032-4315-e063-6294a90a4ca1	1
351172	dutasteride 0.5 MG Oral Capsule	SCD	2ad309b1-4497-8b9b-e063-6394a90aa9b4	1
351172	dutasteride 0.5 MG Oral Capsule	SCD	369f73b9-e032-4315-e063-6294a90a4ca1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42806-549-09	42806054909	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-09)	2017-11-28	0000-00-00	No	No	Current
42806-549-30	42806054930	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-549-30)	2017-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dutasteride	A-S Medication Solutions	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	3
Dutasteride	NuCare Pharmaceuticals, Inc.	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	1
Dutasteride	Epic Pharma, LLC \| Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL	3
Dutasteride	NuCare Pharmaceuticals, Inc.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	1
Dutasteride	NuCare Pharmaceuticals,Inc.	2018-10-22	HUMAN PRESCRIPTION DRUG LABEL	1