FDA.reportPublic FDA data

Simvastatin

Product NDC
71205-780
11-digit product format
712050780
Labeler code
71205
Product ID
71205-780_b5b47d5b-f953-4e82-99ef-e4e10164095e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077691
Marketing category
ANDA
Marketing start
2006-12-20
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
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
71205-780-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED301
71205-780-60Simvastatin60 in 1 BOTTLETABLET, FILM COATED601
71205-780-90Simvastatin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-780SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230401_b5b47d5b-f953-4e82-99ef-e4e10164095e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSNb5b47d5b-f953-4e82-99ef-e4e10164095e1
312961simvastatin 20 MG Oral TabletSCDb5b47d5b-f953-4e82-99ef-e4e10164095e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-780-307120507803030 TABLET, FILM COATED in 1 BOTTLE (71205-780-30) 2023-03-23NoNoCurrent
71205-780-607120507806060 TABLET, FILM COATED in 1 BOTTLE (71205-780-60) 2023-03-23NoNoCurrent
71205-780-907120507809090 TABLET, FILM COATED in 1 BOTTLE (71205-780-90) 2023-03-23NoNoCurrent