FDA.reportPublic FDA data

ezetimibe and simvastatin

Product NDC
16714-781
11-digit product format
167140781
Labeler code
16714
Product ID
16714-781_0d1ac067-fb51-46db-98da-5efd6a65e9e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe and simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA208699
Marketing category
ANDA
Marketing start
2019-08-19
Marketing end
2026-12-31
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10; 80 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
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208699-001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-27
A208699-002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-27
A208699-003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-27
A208699-004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208699-001AB
A208699-002AB
A208699-003AB
A208699-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208699-001EZETIMIBE AND SIMVASTATIN10MG;10MGTABLET / ORALAB2019-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208699-002EZETIMIBE AND SIMVASTATIN10MG;20MGTABLET / ORALAB2019-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208699-003EZETIMIBE AND SIMVASTATIN10MG;40MGTABLET / ORALAB2019-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208699-004EZETIMIBE AND SIMVASTATIN10MG;80MGTABLET / ORALAB2019-06-27d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208699-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208699-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208699-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208699-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208699-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208699-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208699-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208699-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208699-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208699-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208699-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208699-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208699-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208699-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208699-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208699-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208699-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208699-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208699-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208699-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208699-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208699-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208699-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208699-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208699-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208699-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208699-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208699-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208699-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208699-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208699-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208699-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208699-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208699-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208699-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208699-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208699-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208699-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208699-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208699-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
ezetimibe and simvastatin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1
SIMVASTATIN80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AGG2FN16EVInternal UNII lookup
EOR26LQQ24Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
476345Internal RxNorm lookup
476349Internal RxNorm lookup
476350Internal RxNorm lookup
476351Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52a46269-2262-4052-a3ff-5455523f591fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
93a156a6-903b-1690-4dc3-a57adfaa8c1aProduct name920230322
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b249faa8-b784-47ef-8ad4-031ef248fa73Product name120200626
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-781-01ezetimibe and simvastatin30 in 1 BOTTLETABLET307
16714-781-02ezetimibe and simvastatin90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-781-01EA - Each16714-7814033c347-9fd8-4eaa-9ef5-ac73f4d27e9f12019-11-12
16714-781-02EA - Each16714-781ff31610e-9494-4b8a-ad9f-2a0d0afcaa0b12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-781EZETIMIBE AND SIMVASTATIN TABLET [NORTHSTAR RX LLC]7Current NDC, Legacy NDC, 2 package rows20240928_52a46269-2262-4052-a3ff-5455523f591f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINNORTHSTAR RX LLC52a46269-2262-4052-a3ff-5455523f591f2026-08-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208699
application number: ANDA208699
ndc (product): 16714-781
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINGlenmark Pharmaceuticals Inc., USA32d0e130-1211-44ca-be60-5379ffec96fd2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208699
application number: ANDA208699
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINA-S Medication Solutions2c936363-b483-46c6-936c-a07d8ab0280c2024-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208699
application number: ANDA208699

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN52a46269-2262-4052-a3ff-5455523f591f7
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN52a46269-2262-4052-a3ff-5455523f591f7
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN52a46269-2262-4052-a3ff-5455523f591f7
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN52a46269-2262-4052-a3ff-5455523f591f7
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD52a46269-2262-4052-a3ff-5455523f591f7
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD52a46269-2262-4052-a3ff-5455523f591f7
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD52a46269-2262-4052-a3ff-5455523f591f7
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD52a46269-2262-4052-a3ff-5455523f591f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-781-011671407810130 TABLET in 1 BOTTLE (16714-781-01) 30 tablet2019-08-190000-00-00NoNoCurrent
16714-781-021671407810290 TABLET in 1 BOTTLE (16714-781-02) 90 tablet2019-08-190000-00-00NoNoCurrent