CHLORZOXAZONE

Product NDC
80425-0526
11-digit product format
804250526
Labeler code
80425
Product ID
80425-0526_36c1e480-6aa2-03e2-e063-6294a90a7280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA089853
Marketing category
ANDA
Marketing start
2025-05-29
Substance
CHLORZOXAZONE
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORZOXAZONE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0DE420U8G
Rxcui1088934, 1088936

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a7ba9d15-162f-2741-f0fc-3516be5e88bdProduct name720250114
cbf4a4f8-16cb-4546-a0cc-fd91bbe774f2Product name220240223
0a48cfb8-244e-463e-aa85-fd9bbbc9190aProduct name220200224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0526-1CHLORZOXAZONE30 in 1 BOTTLETABLET301
80425-0526-2CHLORZOXAZONE60 in 1 BOTTLETABLET601
80425-0526-3CHLORZOXAZONE90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1088934chlorzoxazone 375 MG Oral TabletPSN36c1eb43-8840-8d84-e063-6394a90addca1
1088936chlorzoxazone 750 MG Oral TabletPSN36c1eb43-8840-8d84-e063-6394a90addca1
1088934chlorzoxazone 375 MG Oral TabletSCD36c1eb43-8840-8d84-e063-6394a90addca1
1088936chlorzoxazone 750 MG Oral TabletSCD36c1eb43-8840-8d84-e063-6394a90addca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0526-18042505260130 TABLET in 1 BOTTLE (80425-0526-1) 30 tablet2025-05-29NoNoCurrent
80425-0526-28042505260260 TABLET in 1 BOTTLE (80425-0526-2) 60 tablet2025-05-29NoNoCurrent
80425-0526-38042505260390 TABLET in 1 BOTTLE (80425-0526-3) 90 tablet2025-05-29NoNoCurrent