FDA.reportPublic FDA data

NDC 80425-0191-01 - Temazepam

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
80425-0191
Requested NDC
80425-0191-01
Package NDCs from labels
80425-0191-1, 80425-0191-2, 80425-0191-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Temazepam - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0191-1Temazepam20 in 1 BOTTLECAPSULE205
80425-0191-2Temazepam30 in 1 BOTTLECAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0191TEMAZEPAM CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 2 package rows20250101_d83e14ae-9823-e57b-e053-2a95a90a8524.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0191-1EA - Each80425-0191962604b0-87a8-4ea5-80c1-7b0b03cdf45a12023-06-06
80425-0191-2EA - Each80425-019161a91cb3-0736-4380-a334-350db2f01a9812023-06-06

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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
temazepamTEMAZEPAMAphena Pharma Solutions - Tennessee, LLCb2422ca0-2f06-419f-aa0e-88c556b623992024-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071456
rxcui: 198242
rxcui: 198241
unii: CHB1QD2QSS
temazepamTEMAZEPAMBryant Ranch Prepack1e37d59b-b8be-46ef-8706-fffd563a8c152024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485489
unii: CHB1QD2QSS
temazepamTEMAZEPAMBryant Ranch Prepack0e752dda-f00f-4123-b59f-aa911b897a5a2023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198242
unii: CHB1QD2QSS
TemazepamTEMAZEPAMBryant Ranch Prepack74a3db09-94d0-45e1-8c68-da7ca49d3d592023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485489
unii: CHB1QD2QSS
temazepamTEMAZEPAMBryant Ranch Prepack4ae0c582-8b0f-42f9-9b05-f7e1698c51832023-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198242
unii: CHB1QD2QSS
temazepamTEMAZEPAMBryant Ranch Prepack5dc0c671-3cd8-4e75-9e76-19c1c17b30b22023-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071456
rxcui: 198241
unii: CHB1QD2QSS
temazepamTEMAZEPAMProficient Rx LP904b8986-24da-48eb-bb0a-33d41b4eb0052023-06-01Warnings, Adverse reactionsExact identifier
application number: ANDA071456
rxcui: 198241
unii: CHB1QD2QSS
TemazepamTEMAZEPAMAlembic Pharmaceuticals Inc.93b1be7f-ec41-46bb-a258-56cb459e2c922023-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485489
rxcui: 198243
rxcui: 198242
rxcui: 198241
unii: CHB1QD2QSS
TemazepamTEMAZEPAMAlembic Pharmaceuticals Limiteddb839409-8e95-41d3-804e-dcd5d11f49342023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485489
rxcui: 198243
rxcui: 198242
rxcui: 198241
unii: CHB1QD2QSS
temazepamTEMAZEPAMProficient Rx LPccf04879-3ad5-4fc3-89f5-879c978870172022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071456
rxcui: 198242
rxcui: 198241
unii: CHB1QD2QSS
temazepamTEMAZEPAMProficient Rx LP5aaf8c99-cd58-47fc-8bf5-1039a6315ca52021-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198242
unii: CHB1QD2QSS
TemazepamTEMAZEPAMAphena Pharma Solutions - Tennessee, LLC2461dfbd-5704-42f4-bde7-d1461811d8982019-05-17Warnings, Adverse reactionsExact identifier
rxcui: 198242
rxcui: 198241
unii: CHB1QD2QSS
TEMAZEPAMTEMAZEPAMAphena Pharma Solutions - Tennessee, LLC405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc12019-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198243
unii: CHB1QD2QSS

Reported adverse events (FAERS/openFDA)#

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