FDA.reportPublic FDA data

NDC 71335-0045-01 - Lovastatin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71335-0045
Requested NDC
71335-0045-01
Package NDCs from labels
71335-0045-1, 71335-0045-2, 71335-0045-3, 71335-0045-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lovastatin - Bryant Ranch PrepackBryant Ranch Prepack2024-08-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0045-1Lovastatin30 in 1 BOTTLETABLET308
71335-0045-2Lovastatin60 in 1 BOTTLETABLET608
71335-0045-3Lovastatin90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0045LOVASTATIN TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 3 package rows20240822_5684ceb8-a5b2-4fb4-92be-14aabcea3871.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0045-1EA - Each71335-004574c67a06-8077-45f8-92b2-b76602cfd02612018-09-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINREMEDYREPACK INC.9438d8a0-ca5b-4676-aab9-d0241ccff6c92026-07-23Warnings, Adverse reactionsExact identifier
application number: ANDA075991
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.e75b5808-ec66-4da7-90bc-e53611aa1b342026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINPreferred Pharmaceuticals Inc.56680dfa-abe6-4587-b222-364315fd78f42026-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA075991
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.397949f9-ce60-424f-9902-90e65a34f4de2026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.22c9f2d8-7bcd-4415-bbc8-5057200339662026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.ea4df37b-21e9-4dc3-83af-1be1b50bfdc92026-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA075991
rxcui: 197905
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepack030c0f79-6bb5-4876-bf8e-b7a25b25dd382026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepackf5f265a6-2aa5-4205-9159-40133ae93ac02026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINREMEDYREPACK INC.ff040b3c-6790-40d7-bd64-a4073b4a20452026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINLupin Pharmaceuticals, Inc.df7ddf4f-d569-431e-81f1-9129d70431502026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 197905
rxcui: 197904
rxcui: 197903
unii: 9LHU78OQFD
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
LovastatinLOVASTATINREMEDYREPACK INC.a902a95f-072a-4487-99a9-109a93f8b23c2026-04-03Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINLegacy Pharmaceutical Packaging, LLCa4f02fa1-3281-46fa-bd52-323e2644b6f82026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 197905
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepack7fd9d5c7-8025-4049-8b5b-ae3d22db507f2026-03-09Warnings, Adverse reactionsExact identifier
application number: ANDA075991
rxcui: 197903
unii: 9LHU78OQFD
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
LovastatinLOVASTATINNorthwind Health Company, LLCf308fe1c-23a9-6409-e053-2995a90abfd92026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINNorthwind Health Company, LLCca59cbd4-a4c1-aebe-e053-2a95a90ae9682026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINNorthwind Health Company, LLCdb47ddae-c574-427f-e053-2a95a90aae482026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA075991
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINNorthwind Health Company, LLCf99e0b4c-e757-4ccd-e053-6294a90ab7222026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197903
unii: 9LHU78OQFD

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.