FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
71205-711
11-digit product format
712050711
Labeler code
71205
Product ID
71205-711_8b8a3310-04e1-4930-8c69-9f8d470b8925
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-711-20CHLORZOXAZONE20 in 1 BOTTLETABLET202
71205-711-30CHLORZOXAZONE30 in 1 BOTTLETABLET302
71205-711-60CHLORZOXAZONE60 in 1 BOTTLETABLET602
71205-711-90CHLORZOXAZONE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-711-20EA - Each71205-711b9b64c97-2cc3-4b4d-bc5a-edd86f10521612025-06-13
71205-711-30EA - Each71205-71183a22147-d196-44e6-b878-0eb23a65e9fe12022-12-07
71205-711-90EA - Each71205-7114cbcbcb5-77ec-4320-8fc7-50fcf4ce2f3a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-711CHLORZOXAZONE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20250321_0a8ee5fa-f393-4568-81bd-269f9a4cecd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN0a8ee5fa-f393-4568-81bd-269f9a4cecd62
197502chlorzoxazone 500 MG Oral TabletSCD0a8ee5fa-f393-4568-81bd-269f9a4cecd62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-711-207120507112020 TABLET in 1 BOTTLE (71205-711-20) 20 tablet2025-03-12NoNoHistorical
71205-711-307120507113030 TABLET in 1 BOTTLE (71205-711-30) 30 tablet2022-11-030000-00-00NoNoCurrent
71205-711-607120507116060 TABLET in 1 BOTTLE (71205-711-60) 60 tablet2022-11-030000-00-00NoNoCurrent
71205-711-907120507119090 TABLET in 1 BOTTLE (71205-711-90) 90 tablet2022-11-030000-00-00NoNoCurrent