FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
70518-4364
11-digit product format
705184364
Labeler code
70518
Product ID
70518-4364_4986f0f6-a218-6af3-e063-6394a90a34d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA089853
Marketing category
ANDA
Marketing start
2025-06-18
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
70518-4364-0CHLORZOXAZONE90 in 1 BOTTLE, PLASTICTABLET902
70518-4364-1CHLORZOXAZONE60 in 1 BOTTLE, PLASTICTABLET602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN3f73a1d1-b3ee-4678-bc02-3258ec8121272
197502chlorzoxazone 500 MG Oral TabletSCD3f73a1d1-b3ee-4678-bc02-3258ec8121272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4364-07051843640090 TABLET in 1 BOTTLE, PLASTIC (70518-4364-0) 90 tablet2025-06-18NoNoHistorical
70518-4364-17051843640160 TABLET in 1 BOTTLE, PLASTIC (70518-4364-1) 60 tablet2026-01-29NoNoHistorical