FDA.reportPublic FDA data

CHLORZOXAZONE

Product NDC
16571-727
11-digit product format
165710727
Labeler code
16571
Product ID
16571-727_b4a7f61d-613e-4d8f-a3fc-37143c6e19c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORZOXAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA213126
Marketing category
ANDA
Marketing start
2022-04-05
Substance
CHLORZOXAZONE
Active strength
750 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
CHLORZOXAZONE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0DE420U8G
Rxcui197502, 1088934, 1088936

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-727-01CHLORZOXAZONE100 in 1 BOTTLETABLET1004
16571-727-50CHLORZOXAZONE500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-727-01EA - Each16571-727e333f981-3dc6-455f-8685-74a862dcdddd12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-727CHLORZOXAZONE TABLET [RISING PHARMA HOLDINGS, INC.]4Current NDC, Legacy NDC, 2 package rows20230610_1df6058b-7bf2-4246-9827-93fa023a5fd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1088934chlorzoxazone 375 MG Oral TabletPSN1df6058b-7bf2-4246-9827-93fa023a5fd44
197502chlorzoxazone 500 MG Oral TabletPSN1df6058b-7bf2-4246-9827-93fa023a5fd44
1088936chlorzoxazone 750 MG Oral TabletPSN1df6058b-7bf2-4246-9827-93fa023a5fd44
1088934chlorzoxazone 375 MG Oral TabletSCD1df6058b-7bf2-4246-9827-93fa023a5fd44
197502chlorzoxazone 500 MG Oral TabletSCD1df6058b-7bf2-4246-9827-93fa023a5fd44
1088936chlorzoxazone 750 MG Oral TabletSCD1df6058b-7bf2-4246-9827-93fa023a5fd44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-727-0116571072701100 TABLET in 1 BOTTLE (16571-727-01) 100 tablet2022-04-050000-00-00NoNoCurrent
16571-727-5016571072750500 TABLET in 1 BOTTLE (16571-727-50) 500 tablet2022-04-050000-00-00NoNoCurrent