Cyclobenzaprine Hydrochloride

Product NDC
69306-075
11-digit product format
693060075
Labeler code
69306
Product ID
69306-075_cd092b93-57b8-bffc-e053-2a95a90a1a77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Doc Rx
Application
ANDA078722
Marketing category
ANDA
Marketing start
2018-01-16
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

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
69306-075-09Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69306-075-09EA - Each69306-075d12f39f6-fb5c-442f-8fad-ac08293a1bd312021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69306-075CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DOC RX]3Current NDC, Legacy NDC, 1 package rows20210930_64669718-02a0-47c6-9709-5f8db5736e04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN64669718-02a0-47c6-9709-5f8db5736e043
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD64669718-02a0-47c6-9709-5f8db5736e043

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69306-075-096930600750990 TABLET, FILM COATED in 1 BOTTLE (69306-075-09) 2021-01-150000-00-00NoNoCurrent