FDA.reportPublic FDA data

Chlorzoxazone

Product NDC
70954-085
11-digit product format
709540085
Labeler code
70954
Product ID
70954-085_9dce6a48-2f53-4a21-8b9a-736afee9c5f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Novitium Pharma LLC
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
70954-085-10Chlorzoxazone100 in 1 BOTTLETABLET1004
70954-085-20Chlorzoxazone500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-085-10EA - Each70954-0850120466a-b76b-4fe8-b8a0-191ab0e1139a12020-08-06
70954-085-20EA - Each70954-085a42b3f53-5551-4fb2-b6a4-050c81ca882712020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-085CHLORZOXAZONE TABLET [NOVITIUM PHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20211102_69c87a85-4b6b-405b-9fa5-4c91c0f90c70.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
197502chlorzoxazone 500 MG Oral TabletPSN69c87a85-4b6b-405b-9fa5-4c91c0f90c704
197502chlorzoxazone 500 MG Oral TabletSCD69c87a85-4b6b-405b-9fa5-4c91c0f90c704
197502chlorzoxazone 500 MG Oral TabletPSNbccfb7cb-f8af-1a85-e053-2a95a90ad0521
197502chlorzoxazone 500 MG Oral TabletSCDbccfb7cb-f8af-1a85-e053-2a95a90ad0521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-085-1070954008510100 TABLET in 1 BOTTLE (70954-085-10) 100 tablet2019-09-120000-00-00NoNoCurrent
70954-085-2070954008520500 TABLET in 1 BOTTLE (70954-085-20) 500 tablet2019-09-120000-00-00NoNoCurrent