Simvastatin

Product NDC
50090-6389
11-digit product format
500906389
Labeler code
50090
Product ID
50090-6389_797f8859-cfed-4898-9ff0-d50971e0c7a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077691
Marketing category
ANDA
Marketing start
2006-12-20
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

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
A077691-001SIMVASTATINSIMVASTATIN5MGTABLET / ORALAB2006-12-20
A077691-002SIMVASTATINSIMVASTATIN10MGTABLET / ORALAB2006-12-20
A077691-003SIMVASTATINSIMVASTATIN20MGTABLET / ORALAB2006-12-20
A077691-004SIMVASTATINSIMVASTATIN40MGTABLET / ORALAB2006-12-20
A077691-005SIMVASTATINSIMVASTATIN80MGTABLET / ORALAB2006-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077691-001AB
A077691-002AB
A077691-003AB
A077691-004AB
A077691-005AB

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 UTC2026-02A077691-001SIMVASTATIN5MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077691-002SIMVASTATIN10MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077691-003SIMVASTATIN20MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077691-004SIMVASTATIN40MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077691-005SIMVASTATIN80MGTABLET / ORALAB2006-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-001SIMVASTATIN5MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-002SIMVASTATIN10MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-003SIMVASTATIN20MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-004SIMVASTATIN40MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-005SIMVASTATIN80MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077691-001SIMVASTATIN5MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077691-002SIMVASTATIN10MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077691-003SIMVASTATIN20MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077691-004SIMVASTATIN40MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077691-005SIMVASTATIN80MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-001SIMVASTATIN5MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-002SIMVASTATIN10MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-003SIMVASTATIN20MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-004SIMVASTATIN40MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-005SIMVASTATIN80MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-001SIMVASTATIN5MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-002SIMVASTATIN10MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-003SIMVASTATIN20MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-004SIMVASTATIN40MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-005SIMVASTATIN80MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-001SIMVASTATIN5MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-002SIMVASTATIN10MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-003SIMVASTATIN20MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-004SIMVASTATIN40MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-005SIMVASTATIN80MGTABLET / ORALAB2006-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-001SIMVASTATIN5MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-002SIMVASTATIN10MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-003SIMVASTATIN20MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-004SIMVASTATIN40MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-005SIMVASTATIN80MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-001SIMVASTATIN5MGTABLET / ORALAB2006-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-002SIMVASTATIN10MGTABLET / ORALAB2006-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-003SIMVASTATIN20MGTABLET / ORALAB2006-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-004SIMVASTATIN40MGTABLET / ORALAB2006-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-005SIMVASTATIN80MGTABLET / ORALAB2006-12-205bbf6a4d5a75…

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 UTC2026-02A077691-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077691-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077691-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077691-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077691-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077691-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077691-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077691-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077691-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077691-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077691-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077691-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077691-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077691-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077691-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077691-005AB15bbf6a4d5a75…

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
d09f88b5-b95f-4315-9b75-c09ce3d94397Available 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
50090-6389-1Simvastatin30 in 1 BOTTLETABLET, FILM COATED301
50090-6389-2Simvastatin90 in 1 BOTTLETABLET, FILM COATED901
50090-6389-3Simvastatin200 in 1 BOTTLETABLET, FILM COATED2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6389-1EA - Each50090-638947adcaa6-abfd-4efd-860d-a45fef9aea9812023-04-07
50090-6389-2EA - Each50090-63899508aead-825f-454b-97e8-d18cba56ebf012023-04-07
50090-6389-3EA - Each50090-6389cd86cc09-ae4e-4ec3-8044-e72f38e678d712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6389SIMVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20230317_d09f88b5-b95f-4315-9b75-c09ce3d94397.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimvastatinSIMVASTATINBryant Ranch Prepacka3bfe314-1fe4-4d2a-aecb-4194f3bd8f222026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINAurobindo Pharma Limited4724dbb4-3613-4e6a-948f-a43d34f97f062026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINNorthwind Health Company, LLCf7567996-4e81-7c12-e053-6394a90aa0872026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions468f87c8-75e3-444a-baeb-2d0f629802db2025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions02245025-218d-4297-aeb6-91fefa1782912025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions20fa794a-c30a-485e-9e69-3818ba085a0d2025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions9986b59c-aeff-4ccd-8db3-7f1c4e6194202025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions7cbf645d-b1d3-413d-a4c3-c1818ed6dfd12025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions4312637b-1d6a-4d26-a1e8-caffcd7192df2025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutionsa2b879ae-eaf3-4a36-abd0-986add4a73ac2025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions66777aaa-370a-4121-9246-c0866098f4a42025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions658cf877-f7cd-4ec8-84a3-08c27a06ccda2025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions6de29f85-92e9-4a28-9bcc-6789f2f698de2025-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions9133520e-1ffd-4ef1-bced-6b0c9a579f392025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions492f6b4e-ca25-4f59-9f9d-3f465061b7b12025-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.cf85b795-82fa-3389-e053-2995a90af2fd2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.cf859977-2d84-0fcb-e053-2a95a90a62692025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.0a1fe17b-75d4-d361-e063-6394a90ae1882025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINNorthStar Rx LLC0376351b-f1a0-43e5-a0b4-533072c49f392024-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691
SimvastatinSIMVASTATINA-S Medication Solutions2e579278-c105-4cda-92ca-a3496d846c822024-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077691
application number: ANDA077691

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSNd09f88b5-b95f-4315-9b75-c09ce3d943971
312961simvastatin 20 MG Oral TabletSCDd09f88b5-b95f-4315-9b75-c09ce3d943971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6389-15009063890130 TABLET, FILM COATED in 1 BOTTLE (50090-6389-1) 2023-03-09NoNoCurrent
50090-6389-25009063890290 TABLET, FILM COATED in 1 BOTTLE (50090-6389-2) 2023-03-09NoNoCurrent
50090-6389-350090638903200 TABLET, FILM COATED in 1 BOTTLE (50090-6389-3) 2023-03-09NoNoCurrent