FDA.reportPublic FDA data

simvastatin

Product NDC
16729-156
11-digit product format
167290156
Labeler code
16729
Product ID
16729-156_43910ff2-6a21-bf9e-e063-6294a90a3f5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA078155
Marketing category
ANDA
Marketing start
2014-09-12
Substance
SIMVASTATIN
Active strength
5 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
SIMVASTATIN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211, 200345, 312961, 312962, 314231

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
16729-156-10simvastatin30 in 1 BOTTLETABLET, FILM COATED3022
16729-156-15simvastatin90 in 1 BOTTLETABLET, FILM COATED9022
16729-156-17simvastatin1000 in 1 BOTTLETABLET, FILM COATED100022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-156SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]21Current NDC, Legacy NDC, 3 package rows20240719_871251c0-36a1-4a32-9eab-ff6c1e925ca9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312962simvastatin 5 MG Oral TabletPSNc03ab80c-a3ae-4634-a76b-f53740db76f5105
312962simvastatin 5 MG Oral TabletSCDc03ab80c-a3ae-4634-a76b-f53740db76f5105
314231simvastatin 10 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
312961simvastatin 20 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
198211simvastatin 40 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
312962simvastatin 5 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
200345simvastatin 80 MG Oral TabletPSN871251c0-36a1-4a32-9eab-ff6c1e925ca922
314231simvastatin 10 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
312961simvastatin 20 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
198211simvastatin 40 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
312962simvastatin 5 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
200345simvastatin 80 MG Oral TabletSCD871251c0-36a1-4a32-9eab-ff6c1e925ca922
312962simvastatin 5 MG Oral TabletPSN11d83725-d646-4ad4-9930-956beb793ea01
312962simvastatin 5 MG Oral TabletSCD11d83725-d646-4ad4-9930-956beb793ea01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-156-101672901561030 TABLET, FILM COATED in 1 BOTTLE (16729-156-10) 2014-11-070000-00-00NoNoCurrent
16729-156-151672901561590 TABLET, FILM COATED in 1 BOTTLE (16729-156-15) 2014-09-120000-00-00NoNoCurrent
16729-156-17167290156171000 TABLET, FILM COATED in 1 BOTTLE (16729-156-17) 2015-04-220000-00-00NoNoCurrent