Cyclobenzaprine Hydrochloride

Product NDC
50090-1848
11-digit product format
500901848
Labeler code
50090
Product ID
50090-1848_1152b0be-6787-461b-bf78-695595c2c63b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1848-0Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1511
50090-1848-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
50090-1848-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1848-1EA - Each50090-1848efb165de-9058-471c-b9d3-d7af1f4d4c5212022-12-07
50090-1848-2EA - Each50090-1848bed17c18-22b3-4d9c-8713-4641a1003add12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1848CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20231211_81917fa4-c79c-46e2-bfbb-507fc0d7ed1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN81917fa4-c79c-46e2-bfbb-507fc0d7ed1b11
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD81917fa4-c79c-46e2-bfbb-507fc0d7ed1b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1848-05009018480015 TABLET, FILM COATED in 1 BOTTLE (50090-1848-0) 2015-05-280000-00-00NoNoCurrent
50090-1848-15009018480130 TABLET, FILM COATED in 1 BOTTLE (50090-1848-1) 2015-05-280000-00-00NoNoCurrent
50090-1848-25009018480260 TABLET, FILM COATED in 1 BOTTLE (50090-1848-2) 2015-05-280000-00-00NoNoCurrent