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 3 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovastatinLOVASTATINBryant Ranch Prepack8d8199ca-df39-4eb8-a905-dee3ab7e29732024-08-14Warnings, Adverse reactionsExact identifier
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepack5684ceb8-a5b2-4fb4-92be-14aabcea38712024-08-09Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepackad905651-6e3a-4140-aa37-d91e5f37c0f02024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINBryant Ranch Prepacka623c1da-e94e-41be-900c-9e74376d36c82024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINNCS HealthCare of KY, LLC dba Vangard Labs3af47e72-082d-42ad-bde0-294f8101b45c2024-08-05Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197905
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINNuCare Pharmaceuticals, Inc.4aa44b69-2946-2fb1-e054-00144ff8d46c2024-07-19Warnings, Adverse reactionsExact identifier
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINNuCare Pharmaceuticals,Inc.8ccb2a86-cd02-4162-e053-2995a90abe0e2024-06-18Warnings, Adverse reactionsExact identifier
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINNuCare Pharmaceuticals,Inc.19b2bb87-1dc7-cd72-e063-6394a90a0f732024-06-18Warnings, Adverse reactionsExact identifier
application number: ANDA078296
ndc (package): 68071-3615-1
ndc (product): 68071-3615
ndc11 (package): 68071361501
rxcui: 197904
spl id: 1b30c378-b8d4-9650-e063-6394a90ae8f8
spl set id: 19b2bb87-1dc7-cd72-e063-6394a90a0f73
unii: 9LHU78OQFD
LovastatinLOVASTATINNuCare Pharmaceuticals,Inc.1ac7ffb9-860a-fbb6-e063-6294a90a590f2024-06-13Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197903
unii: 9LHU78OQFD
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
LovastatinLOVASTATINAphena Pharma Solutions - Tennessee, LLC0399c35c-513d-48e6-aa20-e8434e3b18d52024-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINAphena Pharma Solutions - Tennessee, LLC7e96b174-3887-4908-9b9f-5ef93540f96a2023-05-31Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINProficient Rx LP2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb2022-12-01Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINProficient Rx LPeb3b4051-3901-461d-a982-7ecd115ba6692022-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA078296
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINProficient Rx LPda9c25c1-f65c-4dc6-8e13-f727c50fd4e42022-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197904
unii: 9LHU78OQFD
LovastatinLOVASTATINProficient Rx LP25efd38a-1495-4824-9137-a3429bc471bd2022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 197905
rxcui: 197904
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINProficient Rx LP4b512c0b-b2f6-4a16-bee6-7669195497ad2021-01-04Warnings, Adverse reactionsExact identifier
rxcui: 197905
unii: 9LHU78OQFD
LovastatinLOVASTATINProficient Rx LPc2b1b926-def3-4411-9aed-395b969028fe2021-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINTeva Pharmaceuticals USA, Inc.0e15feec-d27e-4861-8152-c5a8b8ccacd42020-08-01Warnings, Adverse reactionsExact identifier
rxcui: 197905
rxcui: 197904
rxcui: 197903
unii: 9LHU78OQFD
LovastatinLOVASTATINProficient Rx LP027bd594-6a0a-4e6d-bd3c-4f33fdb4166a2020-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197904
unii: 9LHU78OQFD

Reported adverse events (FAERS/openFDA)#

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