Oxazepam

Product NDC
43353-074
11-digit product format
433530074
Labeler code
43353
Product ID
43353-074_c1cede8c-12ef-4678-be73-35f8b16f2fe3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxazepam
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
ANDA072253
Marketing category
ANDA
Marketing start
2007-01-02
Marketing end
0000-00-00
Substance
OXAZEPAM
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0bf93631-d4c9-1bc6-b689-709626127556Product name220251210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-074-302020-01-31C16284748780-19d75b9d0-9841-f424-e053-dadaa90a57ceOXAZEPAM CAPSULES, USP CIV 40-9021 Revised — January 2008 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-074-30Oxazepam30 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-074-30EA - Each43353-074aebc9748-0bd4-4907-920a-267d9e03c4f712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXAZEPAMACTIVE INGREDIENT6GOW6DWN2AOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
OXAZEPAMACTIVE MOIETY6GOW6DWN2AOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-074OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1Legacy NDC, 1 package rows20120815_8b11788c-2386-4c4a-a9b0-de2bdccbadaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198059oxazepam 30 MG Oral CapsulePSN8b11788c-2386-4c4a-a9b0-de2bdccbadaa1
198059oxazepam 30 MG Oral CapsuleSCD8b11788c-2386-4c4a-a9b0-de2bdccbadaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-074-304335300743030 in 1 BOTTLE, PLASTICHistorical