FDA.reportPublic FDA data

Lovastatin

Product NDC
67544-225
11-digit product format
675440225
Labeler code
67544
Product ID
67544-225_0c57c932-2720-4ab0-8ae4-24983c75130b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075636
Marketing category
ANDA
Marketing start
2001-12-17
Marketing end
2022-05-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-225DDiscontinued by firm2026-07-31
excluded packagepackage67544-22567544-225-15DDiscontinued by firm2026-07-31
excluded packagepackage67544-22567544-225-30DDiscontinued by firm2026-07-31
excluded packagepackage67544-22567544-225-45DDiscontinued by firm2026-07-31
excluded packagepackage67544-22567544-225-53DDiscontinued by firm2026-07-31
excluded packagepackage67544-22567544-225-60DDiscontinued by firm2026-07-31
excluded packagepackage67544-22567544-225-80DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075636-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2001-12-17
A075636-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075636-003LOVASTATINLOVASTATIN40MGTABLET / ORALAB2001-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075636-001AB
A075636-002AB
A075636-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075636-001LOVASTATIN10MGTABLET / ORALAB2001-12-17a50c72e98297…
2026-08-01 22:54:322026-06A075636-002LOVASTATIN20MGTABLET / ORALAB2001-12-17a50c72e98297…
2026-08-01 22:54:322026-06A075636-003LOVASTATIN40MGTABLET / ORALAB2001-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075636-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075636-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075636-003AB1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-225-15EA - Each67544-225b3eba9c5-5730-40c5-8884-dc1268e7747412014-06-03
67544-225-30EA - Each67544-225744505b3-a33c-4b0c-9d89-6d38566f9f4612014-06-03
67544-225-45EA - Each67544-22592b519ec-72f5-4a6b-b582-a3eca32e774b12014-06-03
67544-225-53EA - Each67544-2259f73f164-2e3d-47df-8762-ef619c48917312014-09-03
67544-225-60EA - Each67544-2254289e2ae-ba1a-4de0-8dd6-d19a0b204b1a12014-06-03
67544-225-80EA - Each67544-2252e109dc5-606c-46c1-8b78-3f5d3cec8e9612014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-225-156754402251515 TABLET in 1 BOTTLE, PLASTIC (67544-225-15) 15 tablet2016-11-102022-05-31NoNoCurrent
67544-225-306754402253030 TABLET in 1 BOTTLE, PLASTIC (67544-225-30) 30 tablet2004-09-222022-05-31NoNoCurrent
67544-225-456754402254545 TABLET in 1 BOTTLE, PLASTIC (67544-225-45) 45 tablet2016-10-252022-05-31NoNoCurrent
67544-225-536754402255360 TABLET in 1 BOTTLE, PLASTIC (67544-225-53) 60 tablet2016-10-252022-05-31NoNoCurrent
67544-225-606754402256090 TABLET in 1 BOTTLE, PLASTIC (67544-225-60) 90 tablet2004-08-242022-05-31NoNoCurrent
67544-225-8067544022580180 TABLET in 1 BOTTLE, PLASTIC (67544-225-80) 180 tablet2004-09-162022-05-31NoNoCurrent