SIMVASTATIN

Product NDC
68071-2250
11-digit product format
680712250
Labeler code
68071
Product ID
68071-2250_adf42271-76c1-0fd2-e053-2995a90af7eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SIMVASTATIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals.Inc.
Application
ANDA078103
Marketing category
ANDA
Marketing start
2016-02-19
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2250-3SIMVASTATIN30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2250SIMVASTATIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS.INC.]1Legacy NDC, 1 package rows20200829_adf42271-76c0-0fd2-e053-2995a90af7eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSNadf42271-76c0-0fd2-e053-2995a90af7eb1
198211simvastatin 40 MG Oral TabletSCDadf42271-76c0-0fd2-e053-2995a90af7eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2250-36807122500330 TABLET, FILM COATED in 1 BOTTLE (68071-2250-3) 2020-08-280000-00-00NoNoCurrent