FDA.reportPublic FDA data

Lovastatin

Product NDC
67544-106
11-digit product format
675440106
Labeler code
67544
Product ID
67544-106_8eccf91e-8dd6-406a-bfe2-a45d49012d13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions -
Application
ANDA075636
Marketing category
ANDA
Marketing start
2001-12-17
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reducta
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct67544-106DDiscontinued by firm2026-07-31
excluded packagepackage67544-10667544-106-15DDiscontinued by firm2026-07-31
excluded packagepackage67544-10667544-106-30DDiscontinued by firm2026-07-31
excluded packagepackage67544-10667544-106-45DDiscontinued by firm2026-07-31
excluded packagepackage67544-10667544-106-53DDiscontinued by firm2026-07-31
excluded packagepackage67544-10667544-106-60DDiscontinued by firm2026-07-31
excluded packagepackage67544-10667544-106-80DDiscontinued 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
67544-106-15EA - Each67544-106b22eb7cd-0104-466e-9d21-8bc3a13d6bfc12014-06-03
67544-106-30EA - Each67544-106f36b99be-251d-48ba-a760-a73a9093388112014-06-03
67544-106-45EA - Each67544-106de56ce9f-3d3e-4e6c-b5fc-ba93bceab81312014-06-03
67544-106-53EA - Each67544-1064684f183-7d58-4a65-81bd-9c471c7ba2f812014-06-03
67544-106-60EA - Each67544-106f13a05fc-40d2-4e35-83b3-0419f752d1e012014-06-03
67544-106-80EA - Each67544-1069d97f90e-4d8c-4050-8c62-65a23efaf6b012014-06-03

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