FDA.reportPublic FDA data

Lovastatin

Product NDC
66267-555
11-digit product format
662670555
Labeler code
66267
Product ID
66267-555_9cbe8225-1b1b-5528-e053-2995a90adea0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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 Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66267-555DDiscontinued by firm2026-07-31
excluded packagepackage66267-55566267-555-30DDiscontinued by firm2026-07-31
excluded packagepackage66267-55566267-555-90DDiscontinued 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…