Cyclobenzaprine Hydrochloride

Product NDC
0440-7350
11-digit product format
004407350
Labeler code
0440
Product ID
0440-7350_1324757d-3074-4293-b4b6-1338abaee8ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
1989-05-03
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
0440-7350-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED101
0440-7350-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
0440-7350-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
0440-7350-81Cyclobenzaprine Hydrochloride300 in 1 BOTTLETABLET, FILM COATED3001
0440-7350-85Cyclobenzaprine Hydrochloride800 in 1 BOTTLETABLET, FILM COATED8001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7350CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 5 package rows20160813_c08a20e2-dfa1-43fd-a054-6ad3046859c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNc08a20e2-dfa1-43fd-a054-6ad3046859c71
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDc08a20e2-dfa1-43fd-a054-6ad3046859c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7350-100044073501010 in 1 BOTTLEHistorical
0440-7350-150044073501515 in 1 BOTTLEHistorical
0440-7350-300044073503030 in 1 BOTTLEHistorical
0440-7350-8100440735081300 in 1 BOTTLEHistorical
0440-7350-8500440735085800 in 1 BOTTLEHistorical