FDA.reportPublic FDA data

Chlorzoxazone

Product NDC
33261-021
11-digit product format
332610021
Labeler code
33261
Product ID
33261-021_a9dbb759-844a-4b12-9fe5-c08c041c49b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA089859
Marketing category
ANDA
Marketing start
2011-08-22
Marketing end
0000-00-00
Substance
CHLORZOXAZONE
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-021-302020-01-31C16284748780-19d75b9d1-24bd-f424-e053-dadaa90a57ceCHLORZOXAZONE TABLETS, USP 500 mg Revised: November 2010 Rx only 195609
33261-021-602020-01-31C16284748780-19d75b9d1-24bd-f424-e053-dadaa90a57ceCHLORZOXAZONE TABLETS, USP 500 mg Revised: November 2010 Rx only 195609
33261-021-902020-01-31C16284748780-19d75b9d1-24bd-f424-e053-dadaa90a57ceCHLORZOXAZONE TABLETS, USP 500 mg Revised: November 2010 Rx only 195609

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-021-30Chlorzoxazone30 in 1 BOTTLE, PLASTICTABLET302
33261-021-60Chlorzoxazone60 in 1 BOTTLE, PLASTICTABLET602
33261-021-90Chlorzoxazone90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-021-30EA - Each33261-02144d6c270-d016-43d0-95f8-a7bcd4dd35ad12015-10-02
33261-021-60EA - Each33261-0219c2823cd-dfd3-4a2e-b8cc-150a57a08a3312015-10-02
33261-021-90EA - Each33261-0215e342962-38cc-40c6-abe0-f5bb3131067c12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-021CHLORZOXAZONE TABLET [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 3 package rows20140102_63f43b2a-dd5b-482c-a00c-7643d91c2292.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN63f43b2a-dd5b-482c-a00c-7643d91c22922
197502chlorzoxazone 500 MG Oral TabletSCD63f43b2a-dd5b-482c-a00c-7643d91c22922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-021-303326100213030 in 1 BOTTLE, PLASTICHistorical
33261-021-603326100216060 in 1 BOTTLE, PLASTICHistorical
33261-021-903326100219090 in 1 BOTTLE, PLASTICHistorical