FDA.reportPublic FDA data

simvastatin

Product NDC
43063-727
11-digit product format
430630727
Labeler code
43063
Product ID
43063-727_51a59af9-3705-17f7-e063-6294a90aed6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
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
SIMVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui314231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
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
43063-727-30simvastatin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3029
43063-727-90simvastatin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-727-30EA - Each43063-727403b23be-92e3-4410-b100-6fbc2862307412017-03-06
43063-727-90EA - Each43063-7276b9c3dbd-5584-4832-811c-2fb497d6c0d412018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-727SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 2 package rows20240815_aa8aed58-691b-472e-8e98-53d0d3f56686.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNaa8aed58-691b-472e-8e98-53d0d3f5668629
314231simvastatin 10 MG Oral TabletSCDaa8aed58-691b-472e-8e98-53d0d3f5668629

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-727-304306307273030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-727-30) 2016-11-090000-00-00NoNoCurrent
43063-727-904306307279090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-727-90) 2018-01-120000-00-00NoNoCurrent