CHLORZOXAZONE

Product NDC
80425-0525
11-digit product format
804250525
Labeler code
80425
Product ID
80425-0525_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
375 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
CHLORZOXAZONE375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0DE420U8G
Rxcui1088934, 1088936

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0525-18042505250130 TABLET in 1 BOTTLE (80425-0525-1) 30 tablet2025-05-29NoNoHistorical
80425-0525-28042505250260 TABLET in 1 BOTTLE (80425-0525-2) 60 tablet2025-05-29NoNoHistorical
80425-0525-38042505250390 TABLET in 1 BOTTLE (80425-0525-3) 90 tablet2025-05-29NoNoHistorical