FDA.reportPublic FDA data

simvastatin

Product NDC
43063-726
11-digit product format
430630726
Labeler code
43063
Product ID
43063-726_51a5a2c0-617d-2186-e063-6394a90acaf2
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
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
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
43063-726-30simvastatin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3029
43063-726-90simvastatin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-726-30EA - Each43063-726d845fbd8-bdaa-48c3-905f-0791b67039fc12017-03-06
43063-726-90EA - Each43063-726827c473e-2e78-49c7-8b93-58f2c48c11ea12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-726SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 2 package rows20240815_7463b093-c2ee-49c3-a08a-e758de66422a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSN7463b093-c2ee-49c3-a08a-e758de66422a29
198211simvastatin 40 MG Oral TabletSCD7463b093-c2ee-49c3-a08a-e758de66422a29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-726-304306307263030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-726-30) 2016-11-070000-00-00NoNoCurrent
43063-726-904306307269090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-726-90) 2019-07-240000-00-00NoNoCurrent