Cyclobenzaprine Hydrochloride

Product NDC
50090-0969
11-digit product format
500900969
Labeler code
50090
Product ID
50090-0969_c626e4d7-55d1-46de-aca8-55147a99e297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077797
Marketing category
ANDA
Marketing start
2007-02-28
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0969-0Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
50090-0969-1Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED204
50090-0969-2Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0969CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 3 package rows20171108_26a289a9-750a-4479-a93d-e8c08c5e58bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN26a289a9-750a-4479-a93d-e8c08c5e58bd4
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD26a289a9-750a-4479-a93d-e8c08c5e58bd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-0969-05009009690030 in 1 BOTTLEHistorical
50090-0969-15009009690120 in 1 BOTTLEHistorical
50090-0969-25009009690290 in 1 BOTTLEHistorical