simvastatin

Product NDC
71610-250
Requested package NDC
71610-250-30
11-digit product format
716100250
Labeler code
71610
Product ID
71610-250_e41229de-e579-41f7-bfc0-a9fcef4abe0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078155
Marketing category
ANDA
Marketing start
2008-02-26
Substance
SIMVASTATIN
Active strength
10 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
A078155-001SIMVASTATINSIMVASTATIN80MGTABLET / ORALAB2008-02-26
A078155-002SIMVASTATINSIMVASTATIN10MGTABLET / ORALAB2008-02-26
A078155-003SIMVASTATINSIMVASTATIN20MGTABLET / ORALAB2008-02-26
A078155-004SIMVASTATINSIMVASTATIN40MGTABLET / ORALAB2008-02-26
A078155-005SIMVASTATINSIMVASTATIN5MGTABLET / ORALAB2013-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078155-001AB
A078155-002AB
A078155-003AB
A078155-004AB
A078155-005AB

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 UTC2026-02A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-001SIMVASTATIN80MGTABLET / ORALAB2008-02-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-002SIMVASTATIN10MGTABLET / ORALAB2008-02-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-003SIMVASTATIN20MGTABLET / ORALAB2008-02-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-004SIMVASTATIN40MGTABLET / ORALAB2008-02-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-005SIMVASTATIN5MGTABLET / ORALAB2013-04-055bbf6a4d5a75…

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 UTC2026-02A078155-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078155-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078155-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078155-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078155-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078155-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078155-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078155-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078155-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078155-005AB15bbf6a4d5a75…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN10 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
314231Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
121b0e00-abb7-4e07-a7b2-311be89fabb7Available 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
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-250-30simvastatin30 in 1 BOTTLETABLET, FILM COATED301
71610-250-45simvastatin45 in 1 BOTTLETABLET, FILM COATED451
71610-250-60simvastatin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-250-30EA - Each71610-250109e431a-fbdc-4574-a04c-aa60d89e79ae12019-05-02
71610-250-45EA - Each71610-250383c6e39-f165-415b-9f2b-7bf48cb1207f12019-05-02
71610-250-60EA - Each71610-250cd858332-1819-471c-9c6c-6095b441c6c012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-250SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20190405_121b0e00-abb7-4e07-a7b2-311be89fabb7.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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.aa8aed58-691b-472e-8e98-53d0d3f566862026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.7463b093-c2ee-49c3-a08a-e758de66422a2026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINPD-Rx Pharmaceuticals, Inc.c6b610ab-7367-4e61-9b4a-7ebbd1cf3d362026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepackc03ab80c-a3ae-4634-a76b-f53740db76f52026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNorthwind Health Company, LLCdb0f4c5a-e8e4-3ab1-e053-2995a90a1f9a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNorthwind Health Company, LLCf32d512f-86fa-b70f-e053-2a95a90afd012026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINQPharma, Inc.c80b823c-b30f-0a9d-e053-2995a90a31e92025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINAccord Healthcare, Inc.871251c0-36a1-4a32-9eab-ff6c1e925ca92025-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.56456210-2db5-4f0d-e054-00144ff8d46c2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepackb6d5fb21-a1a8-53e5-80d9-dde0eede5ef52024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepack356ed6a6-e467-4791-87ff-2ae7779fc1b02024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepackce3ac5e8-bdef-d195-e0a0-e1a982008efe2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINBryant Ranch Prepack79ca09cd-2396-4e50-b159-1f95671150672024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.54c236ce-69c2-06ef-e054-00144ff88e882024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.54c28733-eb99-10f6-e054-00144ff88e882024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.8ed46bb1-9f84-4418-e053-2a95a90abd4b2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINNuCare Pharmaceuticals,Inc.8e986df7-3020-6755-e053-2995a90aca372024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINA-S Medication Solutionsaaeebbc3-2608-41b5-8420-5a2a80316d392023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINProficient Rx LPca760e79-5d8c-4b36-9899-0d37e8e1f24e2022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155
simvastatinSIMVASTATINAphena Pharma Solutions - Tennessee, LLCb5bebcd0-84e6-410d-af96-63834d262bad2021-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078155
application number: ANDA078155

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN121b0e00-abb7-4e07-a7b2-311be89fabb71
314231simvastatin 10 MG Oral TabletSCD121b0e00-abb7-4e07-a7b2-311be89fabb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-250-307161002503030 TABLET, FILM COATED in 1 BOTTLE (71610-250-30) 2019-03-140000-00-00NoNoCurrent