Cyclobenzaprine Hydrochloride

Product NDC
50090-0375
11-digit product format
500900375
Labeler code
50090
Product ID
50090-0375_12bef127-a190-4602-9d2d-7490bdf8996b
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
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
50090-0375-0Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED154
50090-0375-1Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED204
50090-0375-2Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
50090-0375-3Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED604
50090-0375-4Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
50090-0375-6Cyclobenzaprine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED74
50090-0375-7Cyclobenzaprine Hydrochloride14 in 1 BOTTLETABLET, FILM COATED144
50090-0375-8Cyclobenzaprine Hydrochloride21 in 1 BOTTLETABLET, FILM COATED214
50090-0375-9Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0375CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 9 package rows20170927_74e320cd-29ff-4324-b48a-1174c1951cae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN74e320cd-29ff-4324-b48a-1174c1951cae4
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD74e320cd-29ff-4324-b48a-1174c1951cae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-0375-05009003750015 in 1 BOTTLEHistorical
50090-0375-15009003750120 in 1 BOTTLEHistorical
50090-0375-25009003750230 in 1 BOTTLEHistorical
50090-0375-35009003750360 in 1 BOTTLEHistorical
50090-0375-450090037504100 in 1 BOTTLEHistorical
50090-0375-6500900375067 in 1 BOTTLEHistorical
50090-0375-75009003750714 in 1 BOTTLEHistorical
50090-0375-85009003750821 in 1 BOTTLEHistorical
50090-0375-95009003750910 in 1 BOTTLEHistorical