FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
71335-2009
11-digit product format
713352009
Labeler code
71335
Product ID
71335-2009_001576e5-282d-4596-81b1-9275d111434c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
71335-2009-1CHLORZOXAZONE20 in 1 BOTTLETABLET20103
71335-2009-2CHLORZOXAZONE30 in 1 BOTTLETABLET30103
71335-2009-3CHLORZOXAZONE40 in 1 BOTTLETABLET40103
71335-2009-4CHLORZOXAZONE90 in 1 BOTTLETABLET90103
71335-2009-5CHLORZOXAZONE60 in 1 BOTTLETABLET60103
71335-2009-6CHLORZOXAZONE100 in 1 BOTTLETABLET100103
71335-2009-7CHLORZOXAZONE14 in 1 BOTTLETABLET14103
71335-2009-8CHLORZOXAZONE7 in 1 BOTTLETABLET7103
71335-2009-9CHLORZOXAZONE120 in 1 BOTTLETABLET120103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2009-5EA - Each71335-200907ec3273-fc17-432f-a5bd-8339c147e54e12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2009CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 9 package rows20240502_669afcc1-d587-4dc0-8f6e-99109bcfed36.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2009-17133520090120 TABLET in 1 BOTTLE (71335-2009-1) 20 tablet2024-04-030000-00-00NoNoCurrent
71335-2009-27133520090230 TABLET in 1 BOTTLE (71335-2009-2) 30 tablet2024-04-030000-00-00NoNoCurrent
71335-2009-37133520090340 TABLET in 1 BOTTLE (71335-2009-3) 40 tablet2024-04-030000-00-00NoNoCurrent
71335-2009-47133520090490 TABLET in 1 BOTTLE (71335-2009-4) 90 tablet2021-12-030000-00-00NoNoCurrent
71335-2009-57133520090560 TABLET in 1 BOTTLE (71335-2009-5) 60 tablet2022-12-220000-00-00NoNoCurrent
71335-2009-671335200906100 TABLET in 1 BOTTLE (71335-2009-6) 100 tablet2024-04-030000-00-00NoNoCurrent
71335-2009-77133520090714 TABLET in 1 BOTTLE (71335-2009-7) 14 tablet2024-04-030000-00-00NoNoCurrent
71335-2009-8713352009087 TABLET in 1 BOTTLE (71335-2009-8) 7 tablet2024-04-030000-00-00NoNoCurrent
71335-2009-971335200909120 TABLET in 1 BOTTLE (71335-2009-9) 120 tablet2024-04-030000-00-00NoNoCurrent