FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
70518-3349
11-digit product format
705183349
Labeler code
70518
Product ID
70518-3349_4ef38eb6-8ef8-46bd-e063-6294a90a619c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078103
Marketing category
ANDA
Marketing start
2022-01-31
Substance
SIMVASTATIN
Active strength
40 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211

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
70518-3349-0SIMVASTATIN30 in 1 BOXTABLET, FILM COATED3010
70518-3349-1SIMVASTATIN1 in 1 POUCHTABLET, FILM COATED110
70518-3349-2SIMVASTATIN30 in 1 BLISTER PACKTABLET, FILM COATED3010
70518-3349-3SIMVASTATIN90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3349SIMVASTATIN TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 4 package rows20240704_e59bf31f-d880-4d9e-b6c2-5a18a53718f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSNe59bf31f-d880-4d9e-b6c2-5a18a53718f910
198211simvastatin 40 MG Oral TabletSCDe59bf31f-d880-4d9e-b6c2-5a18a53718f910

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3349-07051833490030 POUCH in 1 BOX (70518-3349-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3349-1) 30 pouch2022-01-310000-00-00NoNoCurrent
70518-3349-1705183349011 in 1 POUCHHistorical
70518-3349-27051833490230 TABLET, FILM COATED in 1 BLISTER PACK (70518-3349-2) 2023-02-21NoNoHistorical
70518-3349-37051833490390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3349-3) 2023-04-03NoNoHistorical