FDA.reportPublic FDA data

Chlorzoxazone

Product NDC
80425-0315
11-digit product format
804250315
Labeler code
80425
Product ID
80425-0315_2a9bf621-afbe-7627-e063-6294a90a77a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorzoxazone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA089853
Marketing category
ANDA
Marketing start
2023-04-10
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
80425-0315-1Chlorzoxazone30 in 1 BOTTLETABLET302
80425-0315-2Chlorzoxazone60 in 1 BOTTLETABLET602
80425-0315-3Chlorzoxazone90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0315-1EA - Each80425-0315469ccd9f-223a-4ac6-8a0c-4455ec4f30a912023-06-06
80425-0315-2EA - Each80425-031506126fb5-4e03-40a0-8f86-e334eda55a7912023-06-06
80425-0315-3EA - Each80425-0315d5d0d47b-4608-40f1-af96-a6c9b942a57712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0315CHLORZOXAZONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8ff7293-89b6-b6ee-e053-6394a90a7d39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197502chlorzoxazone 500 MG Oral TabletPSNf8ff7293-89b6-b6ee-e053-6394a90a7d392
197502chlorzoxazone 500 MG Oral TabletSCDf8ff7293-89b6-b6ee-e053-6394a90a7d392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0315-18042503150130 TABLET in 1 BOTTLE (80425-0315-1) 30 tablet2023-04-10NoNoCurrent
80425-0315-28042503150260 TABLET in 1 BOTTLE (80425-0315-2) 60 tablet2023-04-10NoNoCurrent
80425-0315-38042503150390 TABLET in 1 BOTTLE (80425-0315-3) 90 tablet2023-04-10NoNoCurrent