Oxazepam

Product NDC
62584-812
11-digit product format
625840812
Labeler code
62584
Product ID
62584-812_26e63053-7a43-e278-e063-6394a90a23b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxazepam
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA072253
Marketing category
ANDA
Marketing start
2007-12-17
Substance
OXAZEPAM
Active strength
10 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
OXAZEPAM10 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
62584-812-01Oxazepam100 in 1 CARTONCAPSULE, GELATIN COATED10012
62584-812-11Oxazepam1 in 1 BLISTER PACKCAPSULE, GELATIN COATED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62584-812-01EA - Each62584-81262d03de1-4c8c-4910-bcc2-90b30bd6338a12012-07-24
62584-812-11EA - Each62584-81269318af2-79d7-4f0b-8874-dda9f792126312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXAZEPAMACTIVE INGREDIENT6GOW6DWN2AOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
OXAZEPAMACTIVE MOIETY6GOW6DWN2AOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
GELATININACTIVE INGREDIENT2G86QN327LOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62584-812OXAZEPAM CAPSULE, GELATIN COATED [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 2 package rows20241116_03440821-831c-4085-98f9-faa88e98c503.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198057oxazepam 10 MG Oral CapsulePSN03440821-831c-4085-98f9-faa88e98c50312
312134oxazepam 15 MG Oral CapsulePSN03440821-831c-4085-98f9-faa88e98c50312
198059oxazepam 30 MG Oral CapsulePSN03440821-831c-4085-98f9-faa88e98c50312
198057oxazepam 10 MG Oral CapsuleSCD03440821-831c-4085-98f9-faa88e98c50312
312134oxazepam 15 MG Oral CapsuleSCD03440821-831c-4085-98f9-faa88e98c50312
198059oxazepam 30 MG Oral CapsuleSCD03440821-831c-4085-98f9-faa88e98c50312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62584-812-0162584081201100 BLISTER PACK in 1 CARTON (62584-812-01) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (62584-812-11) 100 blister pack2007-12-170000-00-00NoNoCurrent
62584-812-11625840812111 in 1 BLISTER PACKHistorical