SIMVASTATIN

Product NDC
68788-8369
Requested package NDC
68788-8369-1
11-digit product format
687888369
Labeler code
68788
Product ID
68788-8369_7f31ae2f-4403-4305-bfe5-dcdcd83cdd1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA078103
Marketing category
ANDA
Marketing start
2023-02-01
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-1484e616aacf4f…
2026-08-18 06:07:402026-07A078103-001SIMVASTATIN10MGTABLET / ORALAB2007-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078103-002SIMVASTATIN20MGTABLET / ORALAB2007-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078103-003SIMVASTATIN40MGTABLET / ORALAB2007-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078103-004SIMVASTATIN80MGTABLET / ORALABRS2007-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078103-005SIMVASTATIN5MGTABLET / ORALAB2009-04-14caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078103-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078103-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078103-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078103-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078103-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A078103-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078103-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078103-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078103-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078103-005AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
SIMVASTATIN
Listing expiration
2027-12-31

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
e73ec981-e477-4412-befd-7b807aceb32eAvailable 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
68788-8369-1SIMVASTATIN100 in 1 BOTTLETABLET, FILM COATED1003
68788-8369-3SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED303
68788-8369-6SIMVASTATIN60 in 1 BOTTLETABLET, FILM COATED603
68788-8369-9SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8369-1EA - Each68788-8369b96254f7-d3ee-4d2d-95a2-9d5925b3757312023-03-13
68788-8369-3EA - Each68788-8369548aa54c-e990-4443-b742-d420c4f8de9b12023-03-13
68788-8369-6EA - Each68788-83696fec0956-efbd-4212-a4fc-d224074df0f112023-03-13
68788-8369-9EA - Each68788-836986f6b2b4-26c5-44e1-a491-982e33a0692b12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8369SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20240814_e73ec981-e477-4412-befd-7b807aceb32e.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
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.68f6c856-ea98-4872-b4df-a6e9e70444fc2026-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.3f6fad0b-0278-433f-86db-761b673a58032026-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.e73ec981-e477-4412-befd-7b807aceb32e2026-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
ndc (package): 68788-8369-1
ndc (product): 68788-8369
ndc11 (package): 68788836901
SimvastatinSIMVASTATINCardinal Health 107, LLCb2d6c7ac-304b-4cba-974c-d9a23a0699252026-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
SIMVASTATINSIMVASTATINREMEDYREPACK INC.e59bf31f-d880-4d9e-b6c2-5a18a53718f92026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078103
application number: ANDA078103
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNe73ec981-e477-4412-befd-7b807aceb32e3
314231simvastatin 10 MG Oral TabletSCDe73ec981-e477-4412-befd-7b807aceb32e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8369-168788836901100 TABLET, FILM COATED in 1 BOTTLE (68788-8369-1) 2023-02-01NoNoCurrent