FDA.reportPublic FDA data

Lovastatin

Product NDC
68180-469
11-digit product format
681800469
Labeler code
68180
Product ID
68180-469_ebd1b7a8-bc2e-4f09-99b0-1e46a971d4f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lovastatin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197903, 197904, 197905

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
68180-469-01Lovastatin100 in 1 BOTTLETABLET10017
68180-469-03Lovastatin1000 in 1 BOTTLETABLET100017
68180-469-05Lovastatin5000 in 1 BOTTLETABLET500017
68180-469-07Lovastatin60 in 1 BOTTLETABLET6017
68180-469-09Lovastatin90 in 1 BOTTLETABLET9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-469-01EA - Each68180-46975720298-34b2-4d89-98c3-219c54ae9cc512012-07-24
68180-469-03EA - Each68180-469bdafec6a-d7f5-4c1e-ba5e-21083d9a1ccd12012-07-24
68180-469-05EA - Each68180-46999eb3b09-68ed-4aa0-b13a-d21c9eaa5d5212012-07-24
68180-469-07EA - Each68180-46941536c5d-ac07-4af3-89c8-1bdde8f650de12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]5
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.]4
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-469LOVASTATIN TABLET [LUPIN PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 5 package rows20231102_df7ddf4f-d569-431e-81f1-9129d7043150.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197905lovastatin 40 MG Oral TabletPSN030c0f79-6bb5-4876-bf8e-b7a25b25dd38103
197905lovastatin 40 MG Oral TabletSCD030c0f79-6bb5-4876-bf8e-b7a25b25dd38103
197904lovastatin 20 MG Oral TabletPSN02aae38d-ee9d-4c09-a155-b69f221ed3e918
197905lovastatin 40 MG Oral TabletPSN02aae38d-ee9d-4c09-a155-b69f221ed3e918
197905lovastatin 40 MG Oral TabletPSNe75b5808-ec66-4da7-90bc-e53611aa1b3418
197904lovastatin 20 MG Oral TabletSCD02aae38d-ee9d-4c09-a155-b69f221ed3e918
197905lovastatin 40 MG Oral TabletSCD02aae38d-ee9d-4c09-a155-b69f221ed3e918
197905lovastatin 40 MG Oral TabletSCDe75b5808-ec66-4da7-90bc-e53611aa1b3418
197903lovastatin 10 MG Oral TabletPSNdf7ddf4f-d569-431e-81f1-9129d704315017
197904lovastatin 20 MG Oral TabletPSNdf7ddf4f-d569-431e-81f1-9129d704315017
197905lovastatin 40 MG Oral TabletPSNdf7ddf4f-d569-431e-81f1-9129d704315017
197903lovastatin 10 MG Oral TabletSCDdf7ddf4f-d569-431e-81f1-9129d704315017
197904lovastatin 20 MG Oral TabletSCDdf7ddf4f-d569-431e-81f1-9129d704315017
197905lovastatin 40 MG Oral TabletSCDdf7ddf4f-d569-431e-81f1-9129d704315017
197904lovastatin 20 MG Oral TabletPSN3af47e72-082d-42ad-bde0-294f8101b45c15
197905lovastatin 40 MG Oral TabletPSN3af47e72-082d-42ad-bde0-294f8101b45c15
197904lovastatin 20 MG Oral TabletSCD3af47e72-082d-42ad-bde0-294f8101b45c15
197905lovastatin 40 MG Oral TabletSCD3af47e72-082d-42ad-bde0-294f8101b45c15
197904lovastatin 20 MG Oral TabletPSNa4f02fa1-3281-46fa-bd52-323e2644b6f89
197905lovastatin 40 MG Oral TabletPSNa4f02fa1-3281-46fa-bd52-323e2644b6f89
197904lovastatin 20 MG Oral TabletSCDa4f02fa1-3281-46fa-bd52-323e2644b6f89
197905lovastatin 40 MG Oral TabletSCDa4f02fa1-3281-46fa-bd52-323e2644b6f89
197905lovastatin 40 MG Oral TabletPSN397949f9-ce60-424f-9902-90e65a34f4de4
197905lovastatin 40 MG Oral TabletPSNeb3b4051-3901-461d-a982-7ecd115ba6694
197905lovastatin 40 MG Oral TabletSCD397949f9-ce60-424f-9902-90e65a34f4de4
197905lovastatin 40 MG Oral TabletSCDeb3b4051-3901-461d-a982-7ecd115ba6694
197905lovastatin 40 MG Oral TabletPSNf308fe1c-23a9-6409-e053-2995a90abfd93
197905lovastatin 40 MG Oral TabletSCDf308fe1c-23a9-6409-e053-2995a90abfd93
197903lovastatin 10 MG Oral TabletPSN8d2199d5-80bd-497f-8c74-f3e613b9800d1
197903lovastatin 10 MG Oral TabletPSN347c802f-4ea9-41d4-80d6-e4a183f221791
197904lovastatin 20 MG Oral TabletPSN8d2199d5-80bd-497f-8c74-f3e613b9800d1
197904lovastatin 20 MG Oral TabletPSN347c802f-4ea9-41d4-80d6-e4a183f221791
197905lovastatin 40 MG Oral TabletPSN8d2199d5-80bd-497f-8c74-f3e613b9800d1
197905lovastatin 40 MG Oral TabletPSN347c802f-4ea9-41d4-80d6-e4a183f221791
197903lovastatin 10 MG Oral TabletSCD8d2199d5-80bd-497f-8c74-f3e613b9800d1
197903lovastatin 10 MG Oral TabletSCD347c802f-4ea9-41d4-80d6-e4a183f221791
197904lovastatin 20 MG Oral TabletSCD8d2199d5-80bd-497f-8c74-f3e613b9800d1
197904lovastatin 20 MG Oral TabletSCD347c802f-4ea9-41d4-80d6-e4a183f221791
197905lovastatin 40 MG Oral TabletSCD8d2199d5-80bd-497f-8c74-f3e613b9800d1
197905lovastatin 40 MG Oral TabletSCD347c802f-4ea9-41d4-80d6-e4a183f221791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-469-0168180046901100 TABLET in 1 BOTTLE (68180-469-01) 100 tablet2007-11-010000-00-00NoNoCurrent
68180-469-03681800469031000 TABLET in 1 BOTTLE (68180-469-03) 1000 tablet2007-11-010000-00-00NoNoCurrent
68180-469-05681800469055000 TABLET in 1 BOTTLE (68180-469-05) 5000 tablet2007-11-010000-00-00NoNoCurrent
68180-469-076818004690760 TABLET in 1 BOTTLE (68180-469-07) 60 tablet2007-11-010000-00-00NoNoCurrent
68180-469-096818004690990 TABLET in 1 BOTTLE (68180-469-09) 90 tablet2007-11-010000-00-00NoNoCurrent