FDA.reportPublic FDA data

Chlorzoxazone

Product NDC
71335-1914
11-digit product format
713351914
Labeler code
71335
Product ID
71335-1914_fc8abd66-24d1-cd1a-e053-6394a90afa7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212254
Marketing category
ANDA
Marketing start
2019-09-12
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
0a48cfb8-244e-463e-aa85-fd9bbbc9190aProduct name220200224
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1914-1Chlorzoxazone20 in 1 BOTTLETABLET20103
71335-1914-2Chlorzoxazone30 in 1 BOTTLETABLET30103
71335-1914-3Chlorzoxazone40 in 1 BOTTLETABLET40103
71335-1914-4Chlorzoxazone90 in 1 BOTTLETABLET90103
71335-1914-5Chlorzoxazone60 in 1 BOTTLETABLET60103
71335-1914-6Chlorzoxazone100 in 1 BOTTLETABLET100103
71335-1914-7Chlorzoxazone14 in 1 BOTTLETABLET14103
71335-1914-8Chlorzoxazone7 in 1 BOTTLETABLET7103
71335-1914-9Chlorzoxazone120 in 1 BOTTLETABLET120103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1914-2EA - Each71335-191458c94390-4929-437c-961b-d104887b8e0a12021-11-09
71335-1914-4EA - Each71335-1914c3355ca7-8bbe-4225-adba-81a6cc17cd0012021-11-09
71335-1914-5EA - Each71335-19148e7435e2-5b1a-43f6-b3d1-9cde1462ae5a12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1914CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 9 package rows20230602_267a0a2a-b818-47d9-9b61-28be172de99a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN267a0a2a-b818-47d9-9b61-28be172de99a103
197502chlorzoxazone 500 MG Oral TabletSCD267a0a2a-b818-47d9-9b61-28be172de99a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1914-17133519140120 TABLET in 1 BOTTLE (71335-1914-1) 20 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-27133519140230 TABLET in 1 BOTTLE (71335-1914-2) 30 tablet2021-08-100000-00-00NoNoCurrent
71335-1914-37133519140340 TABLET in 1 BOTTLE (71335-1914-3) 40 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-47133519140490 TABLET in 1 BOTTLE (71335-1914-4) 90 tablet2021-07-140000-00-00NoNoCurrent
71335-1914-57133519140560 TABLET in 1 BOTTLE (71335-1914-5) 60 tablet2021-09-160000-00-00NoNoCurrent
71335-1914-671335191406100 TABLET in 1 BOTTLE (71335-1914-6) 100 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-77133519140714 TABLET in 1 BOTTLE (71335-1914-7) 14 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-8713351914087 TABLET in 1 BOTTLE (71335-1914-8) 7 tablet2021-10-250000-00-00NoNoCurrent
71335-1914-971335191409120 TABLET in 1 BOTTLE (71335-1914-9) 120 tablet2021-10-250000-00-00NoNoCurrent