Ezetimibe

Product NDC: 71335-2123
11-digit product format: 713352123
Labeler code: 71335
Product ID: 71335-2123_34f7bf4b-9cfb-6931-e063-6394a90abab1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209838
Marketing category: ANDA
Marketing start: 2017-08-25
Substance: EZETIMIBE
Active strength: 10 mg/1
Pharmacologic classes: Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [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 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
A209838-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209838-001	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	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209838-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-08-25	`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	A209838-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209838-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209838-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209838-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209838-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209838-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209838-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209838-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209838-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209838-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209838-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209838-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209838-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209838-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209838-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209838-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209838-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209838-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209838-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209838-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209838-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209838-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209838-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209838-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209838-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209838-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209838-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209838-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209838-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209838-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209838-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209838-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209838-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209838-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209838-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209838-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209838-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209838-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209838-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209838-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EZETIMIBE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EOR26LQQ24	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349556	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
3a80b668-51cd-42be-8497-8712b0508422	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
91774e91-b249-45e3-8ff8-4b5db2927a69	Product name	1	20230718
93a156a6-903b-1690-4dc3-a57adfaa8c1a	Product name	9	20230322
c8f25656-847a-4de8-96a7-06bf98d83c2b	Product name	1	20210916
b249faa8-b784-47ef-8ad4-031ef248fa73	Product name	1	20200626
c4422d73-8e69-1539-606a-32a25fa00ebc	Product name	4	20190926
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2123-1	Ezetimibe	30 in 1 BOTTLE	TABLET	30	103
71335-2123-2	Ezetimibe	90 in 1 BOTTLE	TABLET	90	103
71335-2123-3	Ezetimibe	28 in 1 BOTTLE	TABLET	28	103
71335-2123-4	Ezetimibe	18 in 1 BOTTLE	TABLET	18	103
71335-2123-5	Ezetimibe	60 in 1 BOTTLE	TABLET	60	103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2123	EZETIMIBE TABLET [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 5 package rows	20250514_3a80b668-51cd-42be-8497-8712b0508422.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	A-S Medication Solutions	090776cf-f211-49a3-a993-ff5d707311f2	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	A-S Medication Solutions	a1cc2018-72a3-48bc-90de-c460f224cf5a	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	3a80b668-51cd-42be-8497-8712b0508422	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838 ndc (product): 71335-2123
Ezetimibe	EZETIMIBE	Aurobindo Pharma Limited	726b1e63-437a-4b3b-b773-3ac47a5c0f38	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	NorthStar Rx LLC	5f5644a9-e019-4e5d-ab6f-3d30b1024c5a	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	A-S Medication Solutions	63ecbbf1-a6de-493f-9710-812ff45cb4d3	2024-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	A-S Medication Solutions	57d19491-cba1-4720-b69d-481574459201	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838
Ezetimibe	EZETIMIBE	Proficient Rx LP	8b128e52-5d0d-4536-aa1f-be192d0989ad	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209838 application number: ANDA209838

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EOR26LQQ24	EZETIMIBE	163222-33-1	EZETIMIBE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349556	ezetimibe 10 MG Oral Tablet	PSN	3a80b668-51cd-42be-8497-8712b0508422	103
349556	ezetimibe 10 MG Oral Tablet	SCD	3a80b668-51cd-42be-8497-8712b0508422	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-2123-1	71335212301	30 TABLET in 1 BOTTLE (71335-2123-1)	30 tablet	2022-08-31	0000-00-00	No	No	Current
71335-2123-2	71335212302	90 TABLET in 1 BOTTLE (71335-2123-2)	90 tablet	2022-08-24	0000-00-00	No	No	Current
71335-2123-3	71335212303	28 TABLET in 1 BOTTLE (71335-2123-3)	28 tablet	2024-04-03	0000-00-00	No	No	Current
71335-2123-4	71335212304	18 TABLET in 1 BOTTLE (71335-2123-4)	18 tablet	2024-04-03	0000-00-00	No	No	Current
71335-2123-5	71335212305	60 TABLET in 1 BOTTLE (71335-2123-5)	60 tablet	2023-11-22	0000-00-00	No	No	Current