OXAZEPAM

Product NDC
69315-913
11-digit product format
693150913
Labeler code
69315
Product ID
69315-913_708e4237-a898-4d23-90b1-253c18301884
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXAZEPAM
Dosage form
CAPSULE
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA218261
Marketing category
ANDA
Marketing start
2025-07-09
Substance
OXAZEPAM
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXAZEPAM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXAZEPAM30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GOW6DWN2A
Rxcui198057, 198059, 312134

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-913-01OXAZEPAM100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-913-01EA - Each69315-91350f3cd02-4618-4368-9d70-86d41d1bb31e12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198057oxazepam 10 MG Oral CapsulePSN67f821fa-5663-4d69-82c9-5ee13a09f3243
312134oxazepam 15 MG Oral CapsulePSN67f821fa-5663-4d69-82c9-5ee13a09f3243
198059oxazepam 30 MG Oral CapsulePSN67f821fa-5663-4d69-82c9-5ee13a09f3243
198057oxazepam 10 MG Oral CapsuleSCD67f821fa-5663-4d69-82c9-5ee13a09f3243
312134oxazepam 15 MG Oral CapsuleSCD67f821fa-5663-4d69-82c9-5ee13a09f3243
198059oxazepam 30 MG Oral CapsuleSCD67f821fa-5663-4d69-82c9-5ee13a09f3243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69315-913-0169315091301100 CAPSULE in 1 BOTTLE (69315-913-01) 100 capsule2025-07-09NoNoHistorical