FDA.reportPublic FDA data

Lovastatin

Product NDC
71610-775
11-digit product format
716100775
Labeler code
71610
Product ID
71610-775_2db77596-4171-4597-ba55-045b97d142ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
Substance
LOVASTATIN
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
Lovastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197905

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5Product name120140508
fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-775-30Lovastatin30 in 1 BOTTLE, PLASTICTABLET301
71610-775-45Lovastatin45 in 1 BOTTLE, PLASTICTABLET451
71610-775-53Lovastatin60 in 1 BOTTLE, PLASTICTABLET601
71610-775-60Lovastatin90 in 1 BOTTLE, PLASTICTABLET901
71610-775-80Lovastatin180 in 1 BOTTLE, PLASTICTABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-775-30EA - Each71610-7757b6eaadc-310f-4b2b-805b-108f085b7dce12024-04-05
71610-775-45EA - Each71610-77579910528-f609-454a-b548-0dd838e534aa12024-04-05
71610-775-53EA - Each71610-77546ae082f-accd-4b2a-893d-886ae896782f12024-04-05
71610-775-60EA - Each71610-775ce4ee593-74a9-43fa-ba0c-1fec2ed0ade512024-04-05
71610-775-80EA - Each71610-775cf55d556-6868-4032-b312-c7cd5a9b7c4112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-775LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 5 package rows20240125_0399c35c-513d-48e6-aa20-e8434e3b18d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197905lovastatin 40 MG Oral TabletPSN0399c35c-513d-48e6-aa20-e8434e3b18d51
197905lovastatin 40 MG Oral TabletSCD0399c35c-513d-48e6-aa20-e8434e3b18d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-775-307161007753030 TABLET in 1 BOTTLE, PLASTIC (71610-775-30) 30 tablet2024-01-22NoNoCurrent
71610-775-457161007754545 TABLET in 1 BOTTLE, PLASTIC (71610-775-45) 45 tablet2024-01-22NoNoCurrent
71610-775-537161007755360 TABLET in 1 BOTTLE, PLASTIC (71610-775-53) 60 tablet2024-01-22NoNoCurrent
71610-775-607161007756090 TABLET in 1 BOTTLE, PLASTIC (71610-775-60) 90 tablet2024-01-22NoNoCurrent
71610-775-8071610077580180 TABLET in 1 BOTTLE, PLASTIC (71610-775-80) 180 tablet2024-01-22NoNoCurrent