Cyclobenzaprine Hydrochloride

Product NDC
60760-536
11-digit product format
607600536
Labeler code
60760
Product ID
60760-536_e4438152-1f78-7aa7-e053-2a95a90a61d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St Mary's Medical Park Pharmacy
Application
ANDA078643
Marketing category
ANDA
Marketing start
2022-06-15
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-536-04EA - Each60760-536dd8293ea-4948-490a-8c51-a9b9a2ea4fb912022-08-04
60760-536-15EA - Each60760-536bcb149ad-f287-4175-a6cc-14c30f28170f12022-08-04
60760-536-30EA - Each60760-53697d5384c-789f-4a4b-b15b-71b2d30e079f12022-09-12
60760-536-90EA - Each60760-53668b2197c-146b-49b5-a429-eea03918410c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-536CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ST MARY'S MEDICAL PARK PHARMACY]4Legacy NDC20230316_e39f4ef7-acc0-2d35-e053-2995a90a0f84.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-536-04607600536044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-536-04) 2022-06-150000-00-00NoNoCurrent
60760-536-156076005361515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-536-15) 2022-06-150000-00-00NoNoCurrent
60760-536-306076005363030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-536-30) 2022-06-150000-00-00NoNoCurrent