Chlorzoxazone

Product NDC
55289-633
11-digit product format
552890633
Labeler code
55289
Product ID
55289-633_419b15d3-6522-5d1c-e063-6394a90abbd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA089859
Marketing category
ANDA
Marketing start
2011-08-22
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
55289-633-10Chlorzoxazone10 in 1 BOTTLE, PLASTICTABLET1030
55289-633-20Chlorzoxazone20 in 1 BOTTLE, PLASTICTABLET2030
55289-633-24Chlorzoxazone24 in 1 BOTTLE, PLASTICTABLET2430
55289-633-28Chlorzoxazone28 in 1 BOTTLE, PLASTICTABLET2830
55289-633-30Chlorzoxazone30 in 1 BOTTLE, PLASTICTABLET3030
55289-633-40Chlorzoxazone40 in 1 BOTTLE, PLASTICTABLET4030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-633-10EA - Each55289-633389dff79-c9c7-4c94-9229-e8e320e8d56912012-07-24
55289-633-20EA - Each55289-633eedbd3ae-247e-407a-a00f-f23da2adeb1912012-07-24
55289-633-24EA - Each55289-633dc828efa-4306-4d6e-acf8-54fbb726364612012-07-24
55289-633-28EA - Each55289-633a82c1ce5-cf19-43d9-b24f-1ca0ab0baf3e12012-07-24
55289-633-30EA - Each55289-633ed2e7612-0cae-4fed-a9d6-8f373d94294012012-07-24
55289-633-40EA - Each55289-6338548f2ce-97fe-4a83-9649-97f1df49fec612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORZOXAZONEACTIVE INGREDIENTH0DE420U8GCHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15
CHLORZOXAZONEACTIVE MOIETYH0DE420U8GCHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJCHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-633CHLORZOXAZONE TABLET [PD-RX PHARMACEUTICALS, INC.]29Current NDC, Legacy NDC, 6 package rows20241006_8650d342-92df-48d7-9f3d-cdd6f6f4c0e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN8650d342-92df-48d7-9f3d-cdd6f6f4c0e730
197502chlorzoxazone 500 MG Oral TabletSCD8650d342-92df-48d7-9f3d-cdd6f6f4c0e730

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-633-105528906331010 TABLET in 1 BOTTLE, PLASTIC (55289-633-10) 10 tablet2011-08-310000-00-00NoNoCurrent
55289-633-205528906332020 TABLET in 1 BOTTLE, PLASTIC (55289-633-20) 20 tablet2011-08-310000-00-00NoNoCurrent
55289-633-245528906332424 TABLET in 1 BOTTLE, PLASTIC (55289-633-24) 24 tablet2011-08-310000-00-00NoNoCurrent
55289-633-285528906332828 TABLET in 1 BOTTLE, PLASTIC (55289-633-28) 28 tablet2011-08-310000-00-00NoNoCurrent
55289-633-305528906333030 TABLET in 1 BOTTLE, PLASTIC (55289-633-30) 30 tablet2011-08-310000-00-00NoNoCurrent
55289-633-405528906334040 TABLET in 1 BOTTLE, PLASTIC (55289-633-40) 40 tablet2011-08-310000-00-00NoNoCurrent