Ezetimibe

Product NDC: 0904-7103
11-digit product format: 009047103
Labeler code: 0904
Product ID: 0904-7103_ca6fb267-ef29-4912-a10a-75f2613014f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA209234
Marketing category: ANDA
Marketing start: 2017-12-23
Marketing end: 2027-08-31
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: 2027-12-31
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
A209234-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2017-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209234-001	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	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209234-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2017-12-21	`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	A209234-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209234-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209234-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209234-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209234-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209234-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209234-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209234-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209234-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209234-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209234-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209234-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209234-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209234-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209234-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209234-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209234-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209234-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209234-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209234-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209234-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209234-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209234-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209234-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209234-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209234-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209234-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209234-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209234-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209234-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209234-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209234-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209234-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209234-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209234-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209234-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209234-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209234-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209234-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209234-001	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
e257ed7f-5015-4f1d-93f4-5adf5797643d	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
0904-7103-04	Ezetimibe	1 in 1 BLISTER PACK	TABLET	1	7
0904-7103-04	Ezetimibe	30 in 1 CARTON	TABLET	30	7
0904-7103-10	Ezetimibe	20 in 1 CARTON	TABLET	20	7
0904-7103-10	Ezetimibe	1 in 1 BLISTER PACK	TABLET	1	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7103-04	EA - Each	0904-7103	bba0b232-97a0-456f-8f07-5e368e5dfc27	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7103	EZETIMIBE TABLET [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 4 package rows	20241212_e257ed7f-5015-4f1d-93f4-5adf5797643d.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe	EZETIMIBE	Major Pharmaceuticals	e257ed7f-5015-4f1d-93f4-5adf5797643d	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234 ndc (product): 0904-7103
Ezetimibe	EZETIMIBE	American Health Packaging	0e9a9eda-1b2a-4475-8483-0f410a17c524	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	A-S Medication Solutions	dd8a09cb-f014-4650-9da2-4ad1581c9741	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	Bryant Ranch Prepack	c92292f5-5444-4247-927e-db7bf6816109	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	Ascend Laboratories, LLC	206d702c-b09a-4555-972b-6555d6d6d6e6	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	A-S Medication Solutions	9a04678f-e961-45aa-b3bb-e38e66856edc	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234
Ezetimibe	EZETIMIBE	Proficient Rx LP	fbbe54c3-59a1-436c-aba8-188ba7ca70e0	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209234 application number: ANDA209234

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	e257ed7f-5015-4f1d-93f4-5adf5797643d	7
349556	ezetimibe 10 MG Oral Tablet	SCD	e257ed7f-5015-4f1d-93f4-5adf5797643d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-7103-04	00904710304	30 BLISTER PACK in 1 CARTON (0904-7103-04) / 1 TABLET in 1 BLISTER PACK	30 blister pack	2017-12-23	2027-03-31	No	No	Current
0904-7103-10	00904710310	20 BLISTER PACK in 1 CARTON (0904-7103-10) / 1 TABLET in 1 BLISTER PACK	20 blister pack	2023-08-25	2027-08-31	No	No	Historical