FDA.reportPublic FDA data

NDC 68071-3615-01 - 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
68071-3615
Requested NDC
68071-3615-01
Package NDCs from labels
68071-3615-1, 68071-3615-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx onlyNuCare Pharmaceuticals,Inc.2024-06-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3615-1Lovastatin100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3615LOVASTATIN TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20240620_19b2bb87-1dc7-cd72-e063-6394a90a0f73.zip

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 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINREMEDYREPACK INC.9438d8a0-ca5b-4676-aab9-d0241ccff6c92026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINPD-Rx Pharmaceuticals, Inc.e75b5808-ec66-4da7-90bc-e53611aa1b342026-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINPreferred Pharmaceuticals Inc.56680dfa-abe6-4587-b222-364315fd78f42026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.397949f9-ce60-424f-9902-90e65a34f4de2026-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.22c9f2d8-7bcd-4415-bbc8-5057200339662026-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINPreferred Pharmaceuticals, Inc.ea4df37b-21e9-4dc3-83af-1be1b50bfdc92026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 197905
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepack030c0f79-6bb5-4876-bf8e-b7a25b25dd382026-05-29Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepackf5f265a6-2aa5-4205-9159-40133ae93ac02026-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINBluePoint Laboratories7b86160d-74a9-4774-b5b3-5641e686991f2026-05-27Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197905
rxcui: 197904
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINREMEDYREPACK INC.ff040b3c-6790-40d7-bd64-a4073b4a20452026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINLupin Pharmaceuticals, Inc.df7ddf4f-d569-431e-81f1-9129d70431502026-05-06Warnings, Adverse reactionsExact identifier
application number: ANDA078296
ndc (product): 68180-468
rxcui: 197905
rxcui: 197904
rxcui: 197903
spl id: ebd1b7a8-bc2e-4f09-99b0-1e46a971d4f7
spl set id: df7ddf4f-d569-431e-81f1-9129d7043150
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
application number: ANDA078296
rxcui: 197905
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepack7fd9d5c7-8025-4049-8b5b-ae3d22db507f2026-03-09Warnings, Adverse reactionsExact identifier
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
application number: ANDA078296
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINNorthwind Health Company, LLCca59cbd4-a4c1-aebe-e053-2a95a90ae9682026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINNorthwind Health Company, LLCdb47ddae-c574-427f-e053-2a95a90aae482026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197903
unii: 9LHU78OQFD

Reported adverse events (FAERS/openFDA)#

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