EZETIMIBE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:18:25

Label at a glance#

Productezetimibe

Active ingredientEZETIMIBE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1109-3 in bottle of 30 tablets

Ezetimibe Tablets , 10 mg

Rx only

30 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
349556	ezetimibe 10 MG Oral Tablet	PSN	5
349556	ezetimibe 10 MG Oral Tablet	SCD	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
EZETIMIBE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1109-0	ezetimibe	1000 in 1 BOTTLE	TABLET	1000	5
70771-1109-1	ezetimibe	100 in 1 BOTTLE	TABLET	100	5
70771-1109-2	ezetimibe	10 in 1 BLISTER PACK	TABLET	10	5
70771-1109-3	ezetimibe	30 in 1 BOTTLE	TABLET	30	5
70771-1109-4	ezetimibe	10 in 1 CARTON	TABLET	10	5
70771-1109-5	ezetimibe	500 in 1 BOTTLE	TABLET	500	5
70771-1109-9	ezetimibe	90 in 1 BOTTLE	TABLET	90	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1109	EZETIMIBE TABLET [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 7 package rows	20241201_de814dcd-4759-4e9c-a650-335fb885a79d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

ezetimibe
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1109	70771-1109-3, 70771-1109-9, 70771-1109-1, 70771-1109-5, 70771-1109-0, 70771-1109-2, 70771-1109-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
EZETIMIBE	EOR26LQQ24	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSPOVIDONE	2S7830E561	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204331-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204331-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204331-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-06-12	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204331-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204331-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204331-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204331-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204331-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204331-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204331-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204331-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204331-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204331-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204331-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204331-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204331-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204331-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204331-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204331-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204331-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204331-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204331-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204331-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204331-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204331-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204331-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204331-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204331-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204331-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204331-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204331-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204331-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204331-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204331-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204331-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204331-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204331-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204331-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204331-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204331-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204331-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204331-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204331-001	AB	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ezetimibe	EZETIMIBE	Zydus Lifesciences Limited	de814dcd-4759-4e9c-a650-335fb885a79d	2024-11-28		Exact identifier ndc (package): 70771-1109-9 ndc (package): 70771-1109-5 ndc (package): 70771-1109-4 ndc (package): 70771-1109-1 ndc (package): 70771-1109-2 ndc (package): 70771-1109-3 ndc (package): 70771-1109-0 ndc (product): 70771-1109 ndc11 (package): 70771110900 ndc11 (package): 70771110909 ndc11 (package): 70771110903 ndc11 (package): 70771110902 ndc11 (package): 70771110901 ndc11 (package): 70771110904 ndc11 (package): 70771110905 spl id: 5862da1c-e73d-44ff-a961-aaef469ed646 spl set id: de814dcd-4759-4e9c-a650-335fb885a79d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.