FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui312961

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

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