Chlorzoxazone

Product NDC
53002-5760
11-digit product format
530025760
Labeler code
53002
Product ID
53002-5760_cb876cd6-480a-44ee-85d4-d8875d4fe4a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
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
53002-5760-12025-01-30C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22025-01-30C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32025-01-30C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52025-01-30C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-12023-06-07C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22023-06-07C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32023-06-07C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52023-06-07C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-12023-01-30C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22023-01-30C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32023-01-30C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52023-01-30C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-12020-12-17C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22020-12-17C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32020-12-17C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52020-12-17C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-12020-01-31C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-22020-01-31C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-32020-01-31C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1
53002-5760-52020-01-31C16284748780-19d75b9d0-64de-f424-e053-dadaa90a57ceChlorzoxazone Tablets, USP 500 mg Revised: March 2015 Rx only 195609-1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5760-1Chlorzoxazone10 in 1 BOTTLETABLET105
53002-5760-2Chlorzoxazone20 in 1 BOTTLETABLET205
53002-5760-3Chlorzoxazone30 in 1 BOTTLETABLET305
53002-5760-5Chlorzoxazone15 in 1 BOTTLETABLET155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5760CHLORZOXAZONE TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 4 package rows20230609_3c3c0279-a570-4ded-9f52-5ef345a6753b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN3c3c0279-a570-4ded-9f52-5ef345a6753b5
197502chlorzoxazone 500 MG Oral TabletSCD3c3c0279-a570-4ded-9f52-5ef345a6753b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5760-15300257600110 TABLET in 1 BOTTLE (53002-5760-1) 10 tablet2018-10-010000-00-00NoNoCurrent
53002-5760-25300257600220 TABLET in 1 BOTTLE (53002-5760-2) 20 tablet2018-10-010000-00-00NoNoCurrent
53002-5760-35300257600330 TABLET in 1 BOTTLE (53002-5760-3) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-5760-55300257600515 TABLET in 1 BOTTLE (53002-5760-5) 15 tablet2018-10-010000-00-00NoNoCurrent