FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
59651-306
11-digit product format
596510306
Labeler code
59651
Product ID
59651-306_13956b60-a22d-4ee8-af95-460830ebfbc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA089853
Marketing category
ANDA
Marketing start
2020-08-03
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, 1088934, 1088936

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-306-01CHLORZOXAZONE100 in 1 BOTTLETABLET1004
59651-306-05CHLORZOXAZONE500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-306-01EA - Each59651-3060699408a-853b-4251-8ee6-c2d9e0e8a39612021-07-15
59651-306-05EA - Each59651-30628551f38-363a-451c-9473-431f1ba87b3912021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-306CHLORZOXAZONE TABLET [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20231118_52d3aa2c-f88f-4de7-b5ae-df8a46e94879.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN669afcc1-d587-4dc0-8f6e-99109bcfed36103
197502chlorzoxazone 500 MG Oral TabletSCD669afcc1-d587-4dc0-8f6e-99109bcfed36103
1088934chlorzoxazone 375 MG Oral TabletPSN52d3aa2c-f88f-4de7-b5ae-df8a46e948794
197502chlorzoxazone 500 MG Oral TabletPSN52d3aa2c-f88f-4de7-b5ae-df8a46e948794
1088936chlorzoxazone 750 MG Oral TabletPSN52d3aa2c-f88f-4de7-b5ae-df8a46e948794
1088934chlorzoxazone 375 MG Oral TabletSCD52d3aa2c-f88f-4de7-b5ae-df8a46e948794
197502chlorzoxazone 500 MG Oral TabletSCD52d3aa2c-f88f-4de7-b5ae-df8a46e948794
1088936chlorzoxazone 750 MG Oral TabletSCD52d3aa2c-f88f-4de7-b5ae-df8a46e948794
197502chlorzoxazone 500 MG Oral TabletPSN0a8ee5fa-f393-4568-81bd-269f9a4cecd62
197502chlorzoxazone 500 MG Oral TabletPSN3f73a1d1-b3ee-4678-bc02-3258ec8121272
197502chlorzoxazone 500 MG Oral TabletPSNf8ff7293-89b6-b6ee-e053-6394a90a7d392
197502chlorzoxazone 500 MG Oral TabletSCD0a8ee5fa-f393-4568-81bd-269f9a4cecd62
197502chlorzoxazone 500 MG Oral TabletSCD3f73a1d1-b3ee-4678-bc02-3258ec8121272
197502chlorzoxazone 500 MG Oral TabletSCDf8ff7293-89b6-b6ee-e053-6394a90a7d392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-306-0159651030601100 TABLET in 1 BOTTLE (59651-306-01) 100 tablet2020-08-030000-00-00NoNoCurrent
59651-306-0559651030605500 TABLET in 1 BOTTLE (59651-306-05) 500 tablet2020-08-030000-00-00NoNoCurrent