FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
80425-0507
11-digit product format
804250507
Labeler code
80425
Product ID
80425-0507_30c9d90b-eba6-17be-e063-6394a90a8408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA213126
Marketing category
ANDA
Marketing start
2025-03-20
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
80425-0507-1CHLORZOXAZONE30 in 1 BOTTLETABLET301
80425-0507-2CHLORZOXAZONE60 in 1 BOTTLETABLET601
80425-0507-3CHLORZOXAZONE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0507-1EA - Each80425-050790db2596-d4b9-4bce-97ca-3453f24ef58f12025-05-14
80425-0507-2EA - Each80425-0507dc53fbe8-bd7e-4d12-b134-8cc1b9a5f44412025-05-14
80425-0507-3EA - Each80425-0507e8840893-9961-4080-b38f-48207fa9e30812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0507CHLORZOXAZONE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250322_30c9b3ce-198d-0c16-e063-6394a90a857d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN30c9b3ce-198d-0c16-e063-6394a90a857d1
197502chlorzoxazone 500 MG Oral TabletSCD30c9b3ce-198d-0c16-e063-6394a90a857d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0507-18042505070130 TABLET in 1 BOTTLE (80425-0507-1) 30 tablet2025-03-20NoNoCurrent
80425-0507-28042505070260 TABLET in 1 BOTTLE (80425-0507-2) 60 tablet2025-03-20NoNoCurrent
80425-0507-38042505070390 TABLET in 1 BOTTLE (80425-0507-3) 90 tablet2025-03-20NoNoCurrent