FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
50090-7504
11-digit product format
500907504
Labeler code
50090
Product ID
50090-7504_ff4525dd-9c48-4151-970b-9a184e1f4bf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213126
Marketing category
ANDA
Marketing start
2022-04-05
Substance
CHLORZOXAZONE
Active strength
500 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
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
50090-7504-0CHLORZOXAZONE30 in 1 BOTTLETABLET301
50090-7504-1CHLORZOXAZONE20 in 1 BOTTLETABLET201
50090-7504-3CHLORZOXAZONE60 in 1 BOTTLETABLET601
50090-7504-4CHLORZOXAZONE40 in 1 BOTTLETABLET401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7504-0EA - Each50090-75042ad51bcd-9f7e-4f28-bd61-985a35eda23812025-03-04
50090-7504-1EA - Each50090-750443fb4cce-f1b9-49d9-92de-3be5b91d8f7312025-03-04
50090-7504-3EA - Each50090-7504e13df8cd-9e4e-4eba-b960-27a9da1f856912025-03-04
50090-7504-4EA - Each50090-750440f25845-a347-4cd3-81c4-7df79b3c0f5512025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7504CHLORZOXAZONE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20250205_d0210638-b828-4c05-9669-fd61ef987317.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSNd0210638-b828-4c05-9669-fd61ef9873171
197502chlorzoxazone 500 MG Oral TabletSCDd0210638-b828-4c05-9669-fd61ef9873171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7504-05009075040030 TABLET in 1 BOTTLE (50090-7504-0) 30 tablet2025-01-29NoNoCurrent
50090-7504-15009075040120 TABLET in 1 BOTTLE (50090-7504-1) 20 tablet2025-01-29NoNoCurrent
50090-7504-35009075040360 TABLET in 1 BOTTLE (50090-7504-3) 60 tablet2025-01-29NoNoCurrent
50090-7504-45009075040440 TABLET in 1 BOTTLE (50090-7504-4) 40 tablet2025-01-29NoNoCurrent