FDA.reportPublic FDA data

Chlorzoxazone

Product NDC
63629-1586
11-digit product format
636291586
Labeler code
63629
Product ID
63629-1586_8f1a738f-23de-466c-83ee-f6f2ddd62799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-1586-1Chlorzoxazone20 in 1 BOTTLETABLET209
63629-1586-2Chlorzoxazone30 in 1 BOTTLETABLET309
63629-1586-3Chlorzoxazone40 in 1 BOTTLETABLET409
63629-1586-4Chlorzoxazone90 in 1 BOTTLETABLET909
63629-1586-5Chlorzoxazone60 in 1 BOTTLETABLET609
63629-1586-6Chlorzoxazone100 in 1 BOTTLETABLET1009
63629-1586-7Chlorzoxazone14 in 1 BOTTLETABLET149
63629-1586-8Chlorzoxazone7 in 1 BOTTLETABLET79
63629-1586-9Chlorzoxazone120 in 1 BOTTLETABLET1209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1586-1EA - Each63629-1586727023cb-6cc9-47e7-b435-19082594144512012-07-24
63629-1586-2EA - Each63629-1586bc3b4191-a948-4586-acc3-f7a1bf3d038812012-07-24
63629-1586-3EA - Each63629-1586dd0358a4-ef2e-4754-b3e5-c6548c0755aa12012-07-24
63629-1586-4EA - Each63629-1586455f31f3-da7e-488d-bcf8-1122c31b4cd512012-07-24
63629-1586-5EA - Each63629-1586ba553d15-af5a-434f-ac99-7c0167261d8c12012-07-24
63629-1586-6EA - Each63629-1586dd2e66b1-f4f4-4e49-8da0-70f2c38187c512012-07-24
63629-1586-7EA - Each63629-1586a6b44ee0-e6d1-4597-a5e4-fcff5b3295c812015-02-02
63629-1586-8EA - Each63629-1586bda14c1c-d61b-4db9-bdaa-1cb76e286f6b12015-10-02
63629-1586-9EA - Each63629-1586de34d0b8-0a70-458a-b474-1f311ee8768012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORZOXAZONEACTIVE INGREDIENTH0DE420U8GCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
CHLORZOXAZONEACTIVE MOIETYH0DE420U8GCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1586CHLORZOXAZONE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 9 package rows20241012_5e6889c9-a091-4622-0a00-ad0fc1830f78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN5e6889c9-a091-4622-0a00-ad0fc1830f789
197502chlorzoxazone 500 MG Oral TabletSCD5e6889c9-a091-4622-0a00-ad0fc1830f789

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1586-16362915860120 TABLET in 1 BOTTLE (63629-1586-1) 20 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-26362915860230 TABLET in 1 BOTTLE (63629-1586-2) 30 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-36362915860340 TABLET in 1 BOTTLE (63629-1586-3) 40 tablet2012-10-220000-00-00NoNoCurrent
63629-1586-46362915860490 TABLET in 1 BOTTLE (63629-1586-4) 90 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-56362915860560 TABLET in 1 BOTTLE (63629-1586-5) 60 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-663629158606100 TABLET in 1 BOTTLE (63629-1586-6) 100 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-76362915860714 TABLET in 1 BOTTLE (63629-1586-7) 14 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-8636291586087 TABLET in 1 BOTTLE (63629-1586-8) 7 tablet2024-10-080000-00-00NoNoCurrent
63629-1586-963629158609120 TABLET in 1 BOTTLE (63629-1586-9) 120 tablet2012-07-180000-00-00NoNoCurrent