FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
71335-3122
11-digit product format
713353122
Labeler code
71335
Product ID
71335-3122_873dd349-a1c6-40a4-ab75-2fcad8577456
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210961
Marketing category
ANDA
Marketing start
2024-03-21
Substance
CHLORZOXAZONE
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CHLORZOXAZONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORZOXAZONE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0DE420U8G
Rxcui197502

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
71335-3122-0CHLORZOXAZONE10 in 1 BOTTLETABLET101
71335-3122-1CHLORZOXAZONE20 in 1 BOTTLETABLET201
71335-3122-2CHLORZOXAZONE30 in 1 BOTTLETABLET301
71335-3122-3CHLORZOXAZONE40 in 1 BOTTLETABLET401
71335-3122-4CHLORZOXAZONE90 in 1 BOTTLETABLET901
71335-3122-5CHLORZOXAZONE60 in 1 BOTTLETABLET601
71335-3122-6CHLORZOXAZONE100 in 1 BOTTLETABLET1001
71335-3122-7CHLORZOXAZONE14 in 1 BOTTLETABLET141
71335-3122-8CHLORZOXAZONE7 in 1 BOTTLETABLET71
71335-3122-9CHLORZOXAZONE120 in 1 BOTTLETABLET1201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN6c77ca6b-fda6-43ab-8179-3e0bde6aa65f1
197502chlorzoxazone 500 MG Oral TabletSCD6c77ca6b-fda6-43ab-8179-3e0bde6aa65f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3122-07133531220010 TABLET in 1 BOTTLE (71335-3122-0) 10 tablet2026-04-13NoNoHistorical
71335-3122-17133531220120 TABLET in 1 BOTTLE (71335-3122-1) 20 tablet2026-04-13NoNoHistorical
71335-3122-27133531220230 TABLET in 1 BOTTLE (71335-3122-2) 30 tablet2026-04-13NoNoHistorical
71335-3122-37133531220340 TABLET in 1 BOTTLE (71335-3122-3) 40 tablet2026-04-13NoNoHistorical
71335-3122-47133531220490 TABLET in 1 BOTTLE (71335-3122-4) 90 tablet2026-04-13NoNoHistorical
71335-3122-57133531220560 TABLET in 1 BOTTLE (71335-3122-5) 60 tablet2026-04-13NoNoHistorical
71335-3122-671335312206100 TABLET in 1 BOTTLE (71335-3122-6) 100 tablet2026-04-13NoNoHistorical
71335-3122-77133531220714 TABLET in 1 BOTTLE (71335-3122-7) 14 tablet2026-04-13NoNoHistorical
71335-3122-8713353122087 TABLET in 1 BOTTLE (71335-3122-8) 7 tablet2026-04-13NoNoHistorical
71335-3122-971335312209120 TABLET in 1 BOTTLE (71335-3122-9) 120 tablet2026-04-13NoNoHistorical