Simvastatin

Product NDC
71335-1891
11-digit product format
713351891
Labeler code
71335
Product ID
71335-1891_b410c937-f9a1-4089-8ede-265c2dbc32d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078034
Marketing category
ANDA
Marketing start
2015-12-17
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 42.

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
A078034-001SIMVASTATINSIMVASTATIN5MGTABLET / ORALAB2006-12-20
A078034-002SIMVASTATINSIMVASTATIN10MGTABLET / ORALAB2006-12-20
A078034-003SIMVASTATINSIMVASTATIN20MGTABLET / ORALAB2006-12-20
A078034-004SIMVASTATINSIMVASTATIN40MGTABLET / ORALAB2006-12-20
A078034-005SIMVASTATINSIMVASTATIN80MGTABLET / 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
A078034-001AB
A078034-002AB
A078034-003AB
A078034-004AB
A078034-005AB

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078034-001SIMVASTATIN5MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A078034-002SIMVASTATIN10MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A078034-003SIMVASTATIN20MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A078034-004SIMVASTATIN40MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-08-18 06:07:402026-07A078034-005SIMVASTATIN80MGTABLET / ORALAB2006-12-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078034-001SIMVASTATIN5MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078034-002SIMVASTATIN10MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078034-003SIMVASTATIN20MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078034-004SIMVASTATIN40MGTABLET / ORALAB2006-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078034-005SIMVASTATIN80MGTABLET / ORALAB2006-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-001SIMVASTATIN5MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-002SIMVASTATIN10MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-003SIMVASTATIN20MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-004SIMVASTATIN40MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-005SIMVASTATIN80MGTABLET / ORALAB2006-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078034-001SIMVASTATIN5MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078034-002SIMVASTATIN10MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078034-003SIMVASTATIN20MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078034-004SIMVASTATIN40MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078034-005SIMVASTATIN80MGTABLET / ORALAB2006-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-001SIMVASTATIN5MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-002SIMVASTATIN10MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-003SIMVASTATIN20MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-004SIMVASTATIN40MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-005SIMVASTATIN80MGTABLET / ORALAB2006-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-001SIMVASTATIN5MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-002SIMVASTATIN10MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-003SIMVASTATIN20MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-004SIMVASTATIN40MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-005SIMVASTATIN80MGTABLET / ORALAB2006-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-001SIMVASTATIN5MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-002SIMVASTATIN10MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-003SIMVASTATIN20MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-004SIMVASTATIN40MGTABLET / ORALAB2006-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-005SIMVASTATIN80MGTABLET / ORALAB2006-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-001SIMVASTATIN5MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-002SIMVASTATIN10MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-003SIMVASTATIN20MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-004SIMVASTATIN40MGTABLET / ORALAB2006-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-005SIMVASTATIN80MGTABLET / ORALAB2006-12-202680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078034-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078034-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078034-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078034-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078034-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078034-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078034-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078034-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078034-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078034-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078034-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078034-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078034-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078034-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078034-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078034-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078034-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078034-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078034-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078034-005AB12680178bc6a6…

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
14bd8444-1556-4636-9e56-28da21a852fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1891-1Simvastatin30 in 1 BOTTLETABLET, FILM COATED30102
71335-1891-2Simvastatin60 in 1 BOTTLETABLET, FILM COATED60102
71335-1891-3Simvastatin100 in 1 BOTTLETABLET, FILM COATED100102
71335-1891-4Simvastatin90 in 1 BOTTLETABLET, FILM COATED90102
71335-1891-5Simvastatin120 in 1 BOTTLETABLET, FILM COATED120102
71335-1891-6Simvastatin180 in 1 BOTTLETABLET, FILM COATED180102
71335-1891-7Simvastatin3 in 1 BOTTLETABLET, FILM COATED3102
71335-1891-8Simvastatin10 in 1 BOTTLETABLET, FILM COATED10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1891SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 8 package rows20231031_14bd8444-1556-4636-9e56-28da21a852fc.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC58cd6c9a-3429-24eb-e063-6394a90a69842026-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC55f92c72-e690-85dd-e063-6394a90adb392026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC522d0f7f-f20b-bc17-e063-6294a90a36482026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINREMEDYREPACK INC.d053fee4-b797-4a82-8865-0b4d08b149902026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINREMEDYREPACK INC.807e5be4-6f87-48b4-8a3b-e4ad1061e7062026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINGolden State Medical Supply, Inc.4cc35f5f-2d3e-dedd-e063-6294a90a5cbe2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINNorthwind Health Company, LLCf68e9cf8-a63f-1d64-e053-2a95a90a49232026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINNorthwind Health Company, LLCf2f5ee7a-4f4e-12e9-e053-2a95a90a7eae2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINREMEDYREPACK INC.593f0007-9690-4de5-b1e9-59299e5876432025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINBryant Ranch Prepack4277e75a-7f3b-4f35-ae56-0bbe095586a52024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINBryant Ranch Prepack440dff4b-c377-48f3-bf24-07fd986b6fee2024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINBryant Ranch Prepack14bd8444-1556-4636-9e56-28da21a852fc2023-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
ndc (product): 71335-1891
SimvastatinSIMVASTATINBiocon Pharma Inc,7b325108-6940-50a7-96b4-822a5206e5682023-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINA-S Medication Solutions34c8c080-97b5-4580-b8fb-3fd557cdb40a2023-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLCc0a303c5-6277-47ce-bb8a-bd5400fd82612023-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLCa753846e-4cd5-4ddc-a4f2-c45da571c8832021-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034
SimvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLC37860f3f-984e-419a-a262-3bacc766953e2021-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078034
application number: ANDA078034

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSN14bd8444-1556-4636-9e56-28da21a852fc102
312961simvastatin 20 MG Oral TabletSCD14bd8444-1556-4636-9e56-28da21a852fc102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1891-17133518910130 TABLET, FILM COATED in 1 BOTTLE (71335-1891-1) 2021-07-300000-00-00NoNoCurrent
71335-1891-27133518910260 TABLET, FILM COATED in 1 BOTTLE (71335-1891-2) 2021-12-290000-00-00NoNoCurrent
71335-1891-371335189103100 TABLET, FILM COATED in 1 BOTTLE (71335-1891-3) 2021-12-290000-00-00NoNoCurrent
71335-1891-47133518910490 TABLET, FILM COATED in 1 BOTTLE (71335-1891-4) 2021-06-210000-00-00NoNoCurrent
71335-1891-571335189105120 TABLET, FILM COATED in 1 BOTTLE (71335-1891-5) 2021-12-290000-00-00NoNoCurrent
71335-1891-671335189106180 TABLET, FILM COATED in 1 BOTTLE (71335-1891-6) 2021-12-290000-00-00NoNoCurrent
71335-1891-7713351891073 TABLET, FILM COATED in 1 BOTTLE (71335-1891-7) 2021-12-290000-00-00NoNoCurrent
71335-1891-87133518910810 TABLET, FILM COATED in 1 BOTTLE (71335-1891-8) 2021-12-290000-00-00NoNoCurrent