FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
71205-798
11-digit product format
712050798
Labeler code
71205
Product ID
71205-798_dad0dd7d-3049-4be4-aaeb-8a1895d55208
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078103
Marketing category
ANDA
Marketing start
2007-06-12
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
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
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
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-798-30SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED301
71205-798-60SIMVASTATIN60 in 1 BOTTLETABLET, FILM COATED601
71205-798-90SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-798-30EA - Each71205-798c6a9b255-4b23-4ecb-94a9-bca5377e058212023-08-08
71205-798-90EA - Each71205-798987935b4-05f8-4bd5-80c9-d048ec3a4c0212023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-798SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230520_dad0dd7d-3049-4be4-aaeb-8a1895d55208.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSNdad0dd7d-3049-4be4-aaeb-8a1895d552081
314231simvastatin 10 MG Oral TabletSCDdad0dd7d-3049-4be4-aaeb-8a1895d552081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-798-307120507983030 TABLET, FILM COATED in 1 BOTTLE (71205-798-30) 2023-05-05NoNoCurrent
71205-798-607120507986060 TABLET, FILM COATED in 1 BOTTLE (71205-798-60) 2023-05-05NoNoCurrent
71205-798-907120507989090 TABLET, FILM COATED in 1 BOTTLE (71205-798-90) 2023-05-05NoNoCurrent