CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
60760-365
11-digit product format
607600365
Labeler code
60760
Product ID
60760-365_8ff1c0ac-8cdb-60cf-e053-2a95a90a5645
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA208170
Marketing category
ANDA
Marketing start
2018-06-28
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-365-04EA - Each60760-365e4bc649e-c185-4974-9dc7-b78bb3f9ff4e12018-08-13
60760-365-15EA - Each60760-36555713d9d-e5cb-42a6-a90b-a5b0074f601412018-08-13
60760-365-30EA - Each60760-365afb43d68-c8eb-49b5-955a-453820e2893d12018-09-05
60760-365-90EA - Each60760-365fda5a632-3218-4a07-b6df-e222a27776c112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-365CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]5Legacy NDC20250112_6fb9dfe6-ebc5-7737-e053-2991aa0ad056.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-365-04607600365044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-365-04) 2018-06-280000-00-00NoNoCurrent
60760-365-156076003651515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-365-15) 2018-06-280000-00-00NoNoCurrent
60760-365-306076003653030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-365-30) 2018-06-280000-00-00NoNoCurrent
60760-365-906076003659090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-365-90) 2019-08-070000-00-00NoNoCurrent