FDA.reportPublic FDA data

Simvastatin

Product NDC
71610-623
11-digit product format
716100623
Labeler code
71610
Product ID
71610-623_86b78fe2-ccb5-45de-8746-f8bcbcead975
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078034
Marketing category
ANDA
Marketing start
2015-12-17
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
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
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211, 312961

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
71610-623-15Simvastatin15 in 1 BOTTLETABLET, FILM COATED151
71610-623-30Simvastatin30 in 1 BOTTLETABLET, FILM COATED301
71610-623-45Simvastatin45 in 1 BOTTLETABLET, FILM COATED451
71610-623-60Simvastatin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-623-15EA - Each71610-62321d0bb74-9a25-4d69-aacf-8cd34cab7a9e12022-02-07
71610-623-30EA - Each71610-623443c7098-0803-49a8-b5fd-fb72383ecf9f12022-02-07
71610-623-45EA - Each71610-6238fb64ff3-aa04-40d7-b720-1824a84113d012022-02-07
71610-623-60EA - Each71610-623e502a7a1-4dc0-4adf-a02b-d337325da21112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-623SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20220106_a753846e-4cd5-4ddc-a4f2-c45da571c883.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312961simvastatin 20 MG Oral TabletPSNa753846e-4cd5-4ddc-a4f2-c45da571c8831
198211simvastatin 40 MG Oral TabletPSNa753846e-4cd5-4ddc-a4f2-c45da571c8831
312961simvastatin 20 MG Oral TabletSCDa753846e-4cd5-4ddc-a4f2-c45da571c8831
198211simvastatin 40 MG Oral TabletSCDa753846e-4cd5-4ddc-a4f2-c45da571c8831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-623-157161006231515 TABLET, FILM COATED in 1 BOTTLE (71610-623-15) 2021-12-060000-00-00NoNoCurrent
71610-623-307161006233030 TABLET, FILM COATED in 1 BOTTLE (71610-623-30) 2021-12-060000-00-00NoNoCurrent
71610-623-457161006234545 TABLET, FILM COATED in 1 BOTTLE (71610-623-45) 2021-12-060000-00-00NoNoCurrent
71610-623-607161006236090 TABLET, FILM COATED in 1 BOTTLE (71610-623-60) 2021-12-060000-00-00NoNoCurrent