EZETIMIBE

Product NDC: 31722-628
Requested package NDC: 31722-628-05
11-digit product format: 317220628
Labeler code: 31722
Product ID: 31722-628_1d93c66e-c5ea-de6f-e063-6294a90acfb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: EZETIMIBE
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA210859
Marketing category: ANDA
Marketing start: 2022-07-26
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 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
A210859-001	EZETIMIBE	EZETIMIBE	10MG	TABLET / ORAL	AB		2022-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210859-001	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.

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	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210859-001	EZETIMIBE	10MG	TABLET / ORAL	AB	2022-07-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210859-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210859-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210859-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210859-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210859-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210859-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210859-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210859-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210859-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210859-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210859-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210859-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210859-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210859-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210859-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210859-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210859-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210859-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210859-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210859-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210859-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210859-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210859-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210859-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210859-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210859-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210859-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210859-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210859-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

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
c07fe2e0-dad4-48b5-8a07-7d57a4035ccd	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
31722-628-01	EZETIMIBE	100 in 1 BOTTLE	TABLET	100	2
31722-628-05	EZETIMIBE	500 in 1 BOTTLE	TABLET	500	2
31722-628-10	EZETIMIBE	1000 in 1 BOTTLE	TABLET	1000	2
31722-628-30	EZETIMIBE	30 in 1 BOTTLE	TABLET	30	2
31722-628-31	EZETIMIBE	100 in 1 CARTON	TABLET	100	2
31722-628-31	EZETIMIBE	10 in 1 BLISTER PACK	TABLET	10	2
31722-628-34	EZETIMIBE	10 in 1 BLISTER PACK	TABLET	10	2
31722-628-34	EZETIMIBE	100 in 1 CARTON	TABLET	100	2
31722-628-90	EZETIMIBE	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-628-05	EA - Each	31722-628	3167f94d-43bc-4276-a5a9-89896bd0846d	1	2024-08-12
31722-628-30	EA - Each	31722-628	2404b395-571e-40dd-84c0-a4968e1d9fdc	1	2023-06-06
31722-628-90	EA - Each	31722-628	342205a0-5f2c-48d5-96f9-3ddc3a56f618	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-628	EZETIMIBE (EZETIMIBE) TABLET [CAMBER PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 9 package rows	20240720_c07fe2e0-dad4-48b5-8a07-7d57a4035ccd.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	Bryant Ranch Prepack	02b00cb2-7253-4fb4-a216-53691a929a28	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210859 application number: ANDA210859
EZETIMIBE	EZETIMIBE	A-S Medication Solutions	4cfda5aa-e21a-47b2-b296-88d8336298ef	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210859 application number: ANDA210859
EZETIMIBE	EZETIMIBE	A-S Medication Solutions	4158aa71-3540-4912-b909-7491e5a1429c	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210859 application number: ANDA210859
EZETIMIBE	EZETIMIBE	Camber Pharmaceuticals, Inc.	c07fe2e0-dad4-48b5-8a07-7d57a4035ccd	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210859 application number: ANDA210859 ndc (package): 31722-628-05 ndc (product): 31722-628 ndc11 (package): 31722062805

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	4158aa71-3540-4912-b909-7491e5a1429c	2
349556	ezetimibe 10 MG Oral Tablet	PSN	c07fe2e0-dad4-48b5-8a07-7d57a4035ccd	2
349556	ezetimibe 10 MG Oral Tablet	SCD	4158aa71-3540-4912-b909-7491e5a1429c	2
349556	ezetimibe 10 MG Oral Tablet	SCD	c07fe2e0-dad4-48b5-8a07-7d57a4035ccd	2
349556	ezetimibe 10 MG Oral Tablet	PSN	02b00cb2-7253-4fb4-a216-53691a929a28	1
349556	ezetimibe 10 MG Oral Tablet	PSN	4cfda5aa-e21a-47b2-b296-88d8336298ef	1
349556	ezetimibe 10 MG Oral Tablet	SCD	02b00cb2-7253-4fb4-a216-53691a929a28	1
349556	ezetimibe 10 MG Oral Tablet	SCD	4cfda5aa-e21a-47b2-b296-88d8336298ef	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
31722-628-05	31722062805	500 TABLET in 1 BOTTLE (31722-628-05)	500 tablet	2023-09-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EZETIMIBE	Bryant Ranch Prepack	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	1
EZETIMIBE	A-S Medication Solutions	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	2
EZETIMIBE	A-S Medication Solutions	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	1
EZETIMIBE	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2024-07-19	HUMAN PRESCRIPTION DRUG LABEL	2