FDA.reportPublic FDA data

simvastatin

Product NDC
71610-250
11-digit product format
716100250
Labeler code
71610
Product ID
71610-250_e41229de-e579-41f7-bfc0-a9fcef4abe0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71610-250-30simvastatin30 in 1 BOTTLETABLET, FILM COATED301
71610-250-45simvastatin45 in 1 BOTTLETABLET, FILM COATED451
71610-250-60simvastatin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-250-30EA - Each71610-250109e431a-fbdc-4574-a04c-aa60d89e79ae12019-05-02
71610-250-45EA - Each71610-250383c6e39-f165-415b-9f2b-7bf48cb1207f12019-05-02
71610-250-60EA - Each71610-250cd858332-1819-471c-9c6c-6095b441c6c012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-250SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20190405_121b0e00-abb7-4e07-a7b2-311be89fabb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314231simvastatin 10 MG Oral TabletPSN121b0e00-abb7-4e07-a7b2-311be89fabb71
314231simvastatin 10 MG Oral TabletSCD121b0e00-abb7-4e07-a7b2-311be89fabb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-250-307161002503030 TABLET, FILM COATED in 1 BOTTLE (71610-250-30) 2019-03-140000-00-00NoNoCurrent
71610-250-457161002504545 TABLET, FILM COATED in 1 BOTTLE (71610-250-45) 2019-03-140000-00-00NoNoCurrent
71610-250-607161002506090 TABLET, FILM COATED in 1 BOTTLE (71610-250-60) 2019-03-140000-00-00NoNoCurrent