FDA.reportPublic FDA data

SIMVASTATIN

Product NDC
71205-809
11-digit product format
712050809
Labeler code
71205
Product ID
71205-809_84a02df2-e36f-4505-b0bc-ad8a5d7a0bbe
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
2007-06-14
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
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
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
71205-809-30SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED303
71205-809-90SIMVASTATIN90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-809SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, 2 package rows20240609_8e686832-1caf-425c-9ca6-7eaade43b6fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSN8e686832-1caf-425c-9ca6-7eaade43b6fe3
312961simvastatin 20 MG Oral TabletSCD8e686832-1caf-425c-9ca6-7eaade43b6fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-809-307120508093030 TABLET, FILM COATED in 1 BOTTLE (71205-809-30) 2026-01-27NoNoCurrent
71205-809-907120508099090 TABLET, FILM COATED in 1 BOTTLE (71205-809-90) 2023-05-25NoNoCurrent