Ezetimibe

Product NDC: 68462-226
11-digit product format: 684620226
Labeler code: 68462
Product ID: 68462-226_5009c162-91bb-425a-a688-6237c259d33e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA078560
Marketing category: ANDA
Marketing start: 2022-04-29
Marketing end: 2027-01-01
Substance: EZETIMIBE
Active strength: 10 mg/1
Pharmacologic classes: Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag: No
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
A078560-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2015-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078560-001	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	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078560-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2015-06-26	`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	A078560-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078560-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078560-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078560-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078560-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078560-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078560-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078560-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078560-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078560-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078560-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078560-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078560-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078560-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078560-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078560-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078560-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078560-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078560-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078560-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078560-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078560-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078560-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078560-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078560-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078560-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078560-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078560-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078560-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078560-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078560-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078560-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078560-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078560-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078560-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078560-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078560-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078560-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078560-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078560-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ezetimibe

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
ac539a72-77e4-419c-b1d9-42002e9cecf7	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
68462-226-05	Ezetimibe	500 in 1 BOTTLE	TABLET	500	11
68462-226-10	Ezetimibe	1000 in 1 BOTTLE	TABLET	1000	11
68462-226-11	Ezetimibe	10 in 1 BLISTER PACK	TABLET	10	11
68462-226-11	Ezetimibe	10 in 1 CARTON	TABLET	10	11
68462-226-30	Ezetimibe	30 in 1 BOTTLE	TABLET	30	11
68462-226-90	Ezetimibe	90 in 1 BOTTLE	TABLET	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-226-05	EA - Each	68462-226	75d0a943-086c-4437-a73a-957afaf728b6	1	2022-05-04
68462-226-30	EA - Each	68462-226	42e97552-4158-4102-b192-cadd8ed11dfa	1	2022-05-04
68462-226-90	EA - Each	68462-226	6d8cdd78-e31b-4beb-9857-8956a5df1e6d	1	2022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EZETIMIBE	ACTIVE INGREDIENT	EOR26LQQ24	EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]	1
EZETIMIBE	ACTIVE MOIETY	EOR26LQQ24	EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-226	EZETIMIBE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	10	Current NDC, Legacy NDC, 6 package rows	20240426_ac539a72-77e4-419c-b1d9-42002e9cecf7.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
Ezetimibe	EZETIMIBE	Proficient Rx LP	55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078560 application number: ANDA078560
Ezetimibe	EZETIMIBE	A-S Medication Solutions	5877150f-2807-435e-8e5b-a07dc7dbfd27	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078560 application number: ANDA078560
Ezetimibe	EZETIMIBE	A-S Medication Solutions	1afdb764-c5da-4982-beae-9be61bdcbcdc	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078560 application number: ANDA078560
Ezetimibe	EZETIMIBE	Glenmark Pharmaceuticals Inc., USA	ac539a72-77e4-419c-b1d9-42002e9cecf7	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078560 application number: ANDA078560 ndc (product): 68462-226

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	ac539a72-77e4-419c-b1d9-42002e9cecf7	11
349556	ezetimibe 10 MG Oral Tablet	SCD	ac539a72-77e4-419c-b1d9-42002e9cecf7	11
349556	ezetimibe 10 MG Oral Tablet	PSN	1afdb764-c5da-4982-beae-9be61bdcbcdc	2
349556	ezetimibe 10 MG Oral Tablet	SCD	1afdb764-c5da-4982-beae-9be61bdcbcdc	2
349556	ezetimibe 10 MG Oral Tablet	PSN	55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2	1
349556	ezetimibe 10 MG Oral Tablet	PSN	5877150f-2807-435e-8e5b-a07dc7dbfd27	1
349556	ezetimibe 10 MG Oral Tablet	SCD	55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2	1
349556	ezetimibe 10 MG Oral Tablet	SCD	5877150f-2807-435e-8e5b-a07dc7dbfd27	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-226-05	68462022605	500 TABLET in 1 BOTTLE (68462-226-05)	500 tablet	2022-04-29	2027-01-01	No	No	Current
68462-226-10	68462022610	1000 TABLET in 1 BOTTLE (68462-226-10)	1000 tablet	2022-04-29	2027-01-01	No	No	Current
68462-226-11	68462022611	10 BLISTER PACK in 1 CARTON (68462-226-11) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2022-04-29	2027-01-01	No	No	Current
68462-226-30	68462022630	30 TABLET in 1 BOTTLE (68462-226-30)	30 tablet	2022-04-29	2027-01-01	No	No	Current
68462-226-90	68462022690	90 TABLET in 1 BOTTLE (68462-226-90)	90 tablet	2022-04-29	2027-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ezetimibe	Proficient Rx LP	2025-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
Ezetimibe	A-S Medication Solutions	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	2
Ezetimibe	A-S Medication Solutions	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	1
Ezetimibe	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2024-07-31	HUMAN PRESCRIPTION DRUG LABEL	11