Cyclobenzaprine Hydrochloride

Product NDC
50090-4205
11-digit product format
500904205
Labeler code
50090
Product ID
50090-4205_10576931-fc9b-4400-8406-fca7a9c05aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077563
Marketing category
ANDA
Marketing start
2006-04-04
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4205-02023-01-30C16284748780-1f386c64a-38ff-0266-e053-dadaa90a7c1aCyclobenzaprine Hydrochloride Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4205-0Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4205CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190611_0b9e0dc5-79f5-4ff6-99ca-33ecbda0bb52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN0b9e0dc5-79f5-4ff6-99ca-33ecbda0bb522
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD0b9e0dc5-79f5-4ff6-99ca-33ecbda0bb522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4205-05009042050015 TABLET, FILM COATED in 1 BOTTLE (50090-4205-0) 2019-03-200000-00-00NoNoCurrent