Ezetimibe and Simvastatin

Product NDC: 51407-192
Requested package NDC: 51407-192-30
11-digit product format: 514070192
Labeler code: 51407
Product ID: 51407-192_446023ff-25b4-2c12-e063-6294a90ad27e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ezetimibe and Simvastatin
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA200909
Marketing category: ANDA
Marketing start: 2017-04-26
Marketing end: 2027-09-30
Substance: EZETIMIBE; SIMVASTATIN
Active strength: 10; 40 mg/1; mg/1
Pharmacologic classes: Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200909-001	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26
A200909-002	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26
A200909-003	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26
A200909-004	EZETIMIBE AND SIMVASTATIN	EZETIMIBE; SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A200909-001	AB
A200909-002	AB
A200909-003	AB
A200909-004	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 5 · 164 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	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200909-001	EZETIMIBE AND SIMVASTATIN	10MG;10MG	TABLET / ORAL	AB	2017-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200909-002	EZETIMIBE AND SIMVASTATIN	10MG;20MG	TABLET / ORAL	AB	2017-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200909-003	EZETIMIBE AND SIMVASTATIN	10MG;40MG	TABLET / ORAL	AB	2017-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200909-004	EZETIMIBE AND SIMVASTATIN	10MG;80MG	TABLET / ORAL	AB	2017-04-26	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A200909-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200909-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200909-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200909-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200909-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200909-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200909-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200909-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200909-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200909-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200909-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200909-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200909-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200909-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200909-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200909-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200909-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200909-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200909-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200909-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200909-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200909-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200909-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200909-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200909-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200909-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200909-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200909-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200909-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200909-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200909-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200909-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200909-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200909-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200909-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200909-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200909-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200909-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200909-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200909-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ezetimibe and Simvastatin

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EZETIMIBE	10 mg/1
SIMVASTATIN	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EOR26LQQ24	Internal UNII lookup
AGG2FN16EV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
476345	Internal RxNorm lookup
476349	Internal RxNorm lookup
476350	Internal RxNorm lookup
476351	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
88cd0e7b-e8dc-6125-e053-2a95a90aaa27	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5347abc9-d72b-9efb-f582-cc87efafcf1b	Product name	4	20250729
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
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6	Product name	1	20160615
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
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
51407-192-05	Ezetimibe and Simvastatin	500 in 1 BOTTLE	TABLET	500	7
51407-192-10	Ezetimibe and Simvastatin	1000 in 1 BOTTLE	TABLET	1000	7
51407-192-30	Ezetimibe and Simvastatin	30 in 1 BOTTLE	TABLET	30	7
51407-192-90	Ezetimibe and Simvastatin	90 in 1 BOTTLE	TABLET	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-192-05	EA - Each	51407-192	f31101df-7dc3-4c3e-bbae-140fb7e76812	1	2019-06-19
51407-192-30	EA - Each	51407-192	79b3145d-532e-48d7-852e-34345552e10f	1	2019-06-19
51407-192-90	EA - Each	51407-192	7b4d4f9d-1108-4ed8-b312-a15825dfc329	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-192	EZETIMIBE AND SIMVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY]	6	Current NDC, Legacy NDC, 4 package rows	20231215_88cd0e7b-e8dc-6125-e053-2a95a90aaa27.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	Golden State Medical Supply, Inc.	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200909 application number: ANDA200909 ndc (package): 51407-192-30 ndc (product): 51407-192 ndc11 (package): 51407019230
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	Dr.Reddys Laboratories Inc	023ca87a-1b04-8c17-dc4f-e2758b0771e2	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200909 application number: ANDA200909

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EOR26LQQ24	EZETIMIBE	163222-33-1	EZETIMIBE
AGG2FN16EV	SIMVASTATIN	79902-63-9	SIMVASTATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
476345	ezetimibe 10 MG / simvastatin 10 MG Oral Tablet	PSN	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	7
476349	ezetimibe 10 MG / simvastatin 20 MG Oral Tablet	PSN	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	7
476350	ezetimibe 10 MG / simvastatin 40 MG Oral Tablet	PSN	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	7
476351	ezetimibe 10 MG / simvastatin 80 MG Oral Tablet	PSN	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	7
476345	ezetimibe 10 MG / simvastatin 10 MG Oral Tablet	SCD	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	7
476349	ezetimibe 10 MG / simvastatin 20 MG Oral Tablet	SCD	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	7
476350	ezetimibe 10 MG / simvastatin 40 MG Oral Tablet	SCD	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	7
476351	ezetimibe 10 MG / simvastatin 80 MG Oral Tablet	SCD	88cd0e7b-e8dc-6125-e053-2a95a90aaa27	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-192-30	51407019230	30 TABLET in 1 BOTTLE (51407-192-30)	30 tablet	2019-04-29	2027-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ezetimibe and Simvastatin	Golden State Medical Supply, Inc.	2025-11-24	HUMAN PRESCRIPTION DRUG LABEL	7