FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
61919-478
11-digit product format
619190478
Labeler code
61919
Product ID
61919-478_eac602b2-deb0-d15b-e053-2995a90acc5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA089859
Marketing category
ANDA
Marketing start
2014-01-01
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
2023-12-31
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
0a48cfb8-244e-463e-aa85-fd9bbbc9190aProduct name220200224
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-478-072025-01-30C16284748780-12cef2736-8e84-d83d-e063-dadaa90ab31fCHLORZOXAZONE
61919-478-302025-01-30C16284748780-12cef2736-8e84-d83d-e063-dadaa90ab31fCHLORZOXAZONE
61919-478-402025-01-30C16284748780-12cef2736-8e84-d83d-e063-dadaa90ab31fCHLORZOXAZONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-478-07CHLORZOXAZONE7 in 1 BOTTLETABLET76
61919-478-30CHLORZOXAZONE30 in 1 BOTTLETABLET306
61919-478-40CHLORZOXAZONE40 in 1 BOTTLETABLET406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-478-30EA - Each61919-478795be401-027f-415e-ba37-fb6e2eee6a3212015-05-05
61919-478-40EA - Each61919-47842c2abc8-3e5a-482c-ad5c-c562a6d0b73512015-11-12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-478CHLORZOXAZONE TABLET [DIRECT RX]6Legacy NDC, 3 package rows20221012_0ed64990-f2f2-40e9-be91-874f0a862f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSN0ed64990-f2f2-40e9-be91-874f0a862f836
197502chlorzoxazone 500 MG Oral TabletSCD0ed64990-f2f2-40e9-be91-874f0a862f836

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-478-07619190478077 TABLET in 1 BOTTLE (61919-478-07) 7 tablet2014-01-010000-00-00NoNoCurrent
61919-478-306191904783030 TABLET in 1 BOTTLE (61919-478-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-478-406191904784040 TABLET in 1 BOTTLE (61919-478-40) 40 tablet2014-01-010000-00-00NoNoCurrent