Simvastatin

Product NDC
72189-421
Requested package NDC
72189-421-30
11-digit product format
721890421
Labeler code
72189
Product ID
72189-421_2c4cfec2-fee2-e007-e063-6294a90a3cf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078103
Marketing category
ANDA
Marketing start
2023-02-07
Substance
SIMVASTATIN
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-42172189-421-30UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-42172189-421-30UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078103-001SIMVASTATINSIMVASTATIN10MGTABLET / ORALAB2007-05-11
A078103-002SIMVASTATINSIMVASTATIN20MGTABLET / ORALAB2007-05-11
A078103-003SIMVASTATINSIMVASTATIN40MGTABLET / ORALAB2007-05-11
A078103-004SIMVASTATINSIMVASTATIN80MGTABLET / ORALABRS2007-05-11
A078103-005SIMVASTATINSIMVASTATIN5MGTABLET / ORALAB2009-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A078103-001AB
A078103-002AB
A078103-003AB
A078103-004AB
A078103-005AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-145bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078103-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078103-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078103-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078103-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078103-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078103-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078103-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078103-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078103-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078103-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078103-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078103-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078103-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078103-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078103-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078103-005AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Simvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312961Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f42246de-62d2-212f-e053-2a95a90ac88aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-421-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED304
72189-421-90Simvastatin90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-421-30EA - Each72189-4214f3059ed-e026-4d71-b101-68b8e973711212023-03-13
72189-421-90EA - Each72189-4213b4003ab-46f0-409a-9485-9771da36051612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-421SIMVASTATIN TABLET, FILM COATED [DIRECT_RX]4Current NDC, 2 package rows20250123_f42246de-62d2-212f-e053-2a95a90ac88a.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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMVASTATINSIMVASTATINA-S Medication Solutionse447cc46-adee-4126-8b85-f00f81a6e93c2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINSt. Mary's Medical Park Pharmacyf94d5907-737e-df67-e053-6394a90a82a62026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINSt. Mary's Medical Park Pharmacyfaa81817-3ffa-b83c-e053-6294a90a3f852026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINSt. Mary's Medical Park Pharmacyf94e5e28-f0b1-700a-e053-6394a90adb7b2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINCoupler LLC5257271e-5c07-4996-e063-6394a90a44242026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINCoupler LLC52573b98-6e51-9753-e063-6294a90ac8c42026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINREMEDYREPACK INC.5ae78a86-ccca-4714-b77e-7bc885b674b52026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINQPharma, Incf71fc0ac-223e-18c1-e053-6394a90a45ca2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINCoupler LLC50733b85-067d-99c3-e063-6394a90a42442026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINBryant Ranch Prepack5c760852-800b-463e-8059-06a9a82c22252026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINBryant Ranch Prepack7abc03f8-9d5f-4f7d-9e32-fc463ec0597c2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINREMEDYREPACK INC.e59bf31f-d880-4d9e-b6c2-5a18a53718f92026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINA-S Medication Solutionse4d8ebf3-7f9f-4725-a104-1d1bf6e6f7682026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINA-S Medication Solutions0ccb324f-877d-4f32-a769-7cd1637b7fad2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINPD-Rx Pharmaceuticals, Inc.00896fff-081d-4553-be8c-1999a8a73dda2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINPD-Rx Pharmaceuticals, Inc.143bf1d6-11c5-4a1f-b106-844e0435ee132026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINPD-Rx Pharmaceuticals, Inc.25d9f841-31d8-4514-ac73-ffe138ff69c72026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINBryant Ranch Prepackaaca7284-d2d8-42e3-b153-ddc3d2ce907c2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINBryant Ranch Prepack76ea62f3-4efb-4649-829d-3f0c28d5dae72026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINA-S Medication Solutionsd099d003-4c7c-4e35-ad6e-94ddf20035b72026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSNf42246de-62d2-212f-e053-2a95a90ac88a4
312961simvastatin 20 MG Oral TabletSCDf42246de-62d2-212f-e053-2a95a90ac88a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-421-307218904213030 TABLET, FILM COATED in 1 BOTTLE (72189-421-30) 2023-02-07NoNoCurrent