FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
50090-5772
11-digit product format
500905772
Labeler code
50090
Product ID
50090-5772_338e97bd-601c-4c69-b1a2-aadcb9dd1c36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 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
Cyclobenzaprine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5772-02023-02-07C16284748780-1f386c649-f984-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5772-02023-01-30C16284748780-1f386c649-f984-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5772-0Cyclobenzaprine hydrochloride15 in 1 BOTTLETABLET, FILM COATED1513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5772CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20231204_f3187074-6b55-44a3-b969-40a808eb034a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf3187074-6b55-44a3-b969-40a808eb034a13
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf3187074-6b55-44a3-b969-40a808eb034a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5772-05009057720015 TABLET, FILM COATED in 1 BOTTLE (50090-5772-0) 2021-10-060000-00-00NoNoCurrent