FDA.reportPublic FDA data

NDC 68071-3686-01 - DIAZEPAM

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
68071-3686
Requested NDC
68071-3686-01
Package NDCs from labels
68071-3686-3, 68071-3686-1, 68071-3686-01
Manufacturer
NuCare Pharmaceuticals, Inc
Effective date
2024-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DIAZEPAM - NuCare Pharmaceuticals, IncNuCare Pharmaceuticals, Inc2024-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3686-1DIAZEPAM10 in 1 BOTTLETABLET102
68071-3686-3DIAZEPAM30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3686DIAZEPAM TABLET [NUCARE PHARMACEUTICALS, INC]2Current NDC, 2 package rows20241010_22688087-27ad-620c-e063-6394a90a134c.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 5 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMMeridian Medical Technologies LLCfa352464-14c8-49e9-b8b7-5a968b1cfa932023-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DIAZEPAMDIAZEPAMAurobindo Pharma Limited2f799120-0d08-47cd-8183-a98f0267c8452023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217843
ndc (product): 59651-653
rxcui: 197591
rxcui: 197590
rxcui: 197589
spl id: 2f799120-0d08-47cd-8183-a98f0267c845
spl set id: 2f799120-0d08-47cd-8183-a98f0267c845
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMBryant Ranch Prepackf2fc6f38-d627-4fb3-9be2-5e119ee7e1e12023-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMAmerican Health Packagingaeadf0b0-918b-40e0-a5e8-60b2fcbd5ded2023-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMMedical Purchasing Solutions, LLCc8e979a8-af6b-f0c4-e053-2995a90ae63f2023-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMMedical Purchasing Solutions, LLCc8e95ff5-c177-1ec3-e053-2995a90a6d782023-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
Diazepam IntensolDIAZEPAM INTENSOLHikma Pharmaceuticals USA Inc.1aaf9375-ae3d-4fed-9cd1-24102e00be1a2022-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLC9cf031ae-d59b-430d-9b15-415ae2e49c982022-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMProficient Rx LPf8d26f65-a015-4bfc-b1fa-8595d72af48c2022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMProficient Rx LPe7542d46-2586-4225-b07d-2633116bfa0a2022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197591
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMPharmaceutical Associates, Inc.b24f1eb7-3dab-4183-b81f-f86ac62aedd82021-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLCbdb8feda-01c6-45bd-bd66-97196ccce70c2019-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLCb29916fb-1781-4112-9c3e-45478754d6382017-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197590
unii: Q3JTX2Q7TU

Reported adverse events (FAERS/openFDA)#

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