Cyclobenzaprine Hydrochloride

Product NDC
50090-5896
11-digit product format
500905896
Labeler code
50090
Product ID
50090-5896_638ffdaa-32f2-49b8-9590-65b7eefb5e7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071611
Marketing category
ANDA
Marketing start
2021-07-20
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
2023-12-31
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
50090-5896-0Cyclobenzaprine Hydrochloride3 in 1 BOTTLETABLET, FILM COATED31
50090-5896-1Cyclobenzaprine Hydrochloride12 in 1 BOTTLETABLET, FILM COATED121
50090-5896-8Cyclobenzaprine Hydrochloride6 in 1 BOTTLETABLET, FILM COATED61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5896-1EA - Each50090-5896d5849b90-21e1-4437-b63d-ff8082a71a2912022-06-06
50090-5896-8EA - Each50090-5896f8f8714a-6972-4219-8e57-e3f2c7ccc2a512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5896CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 3 package rows20220122_89437fa6-cf30-49f7-89f3-bbc699ae2856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN89437fa6-cf30-49f7-89f3-bbc699ae28561
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD89437fa6-cf30-49f7-89f3-bbc699ae28561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5896-0500905896003 TABLET, FILM COATED in 1 BOTTLE (50090-5896-0) 2022-01-130000-00-00NoNoCurrent
50090-5896-15009058960112 TABLET, FILM COATED in 1 BOTTLE (50090-5896-1) 2022-01-210000-00-00NoNoCurrent
50090-5896-8500905896086 TABLET, FILM COATED in 1 BOTTLE (50090-5896-8) 2022-01-210000-00-00NoNoCurrent