FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
60760-767
11-digit product format
607600767
Labeler code
60760
Product ID
60760-767_524690da-4868-e81a-e063-6394a90a8366
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
2017-05-31
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828348

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
60760-767-04CYCLOBENZAPRINE HYDROCHLORIDE4 in 1 BOTTLE, PLASTICTABLET, FILM COATED47
60760-767-09CYCLOBENZAPRINE HYDROCHLORIDE9 in 1 BOTTLE, PLASTICTABLET, FILM COATED97
60760-767-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED157
60760-767-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET, FILM COATED207
60760-767-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307
60760-767-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-767-04EA - Each60760-767251bed58-971d-47e2-979f-fcc3111a4daa12023-08-08
60760-767-09EA - Each60760-767d6fddfd9-9925-48ac-be7c-aaefb51cf0a812023-09-05
60760-767-15EA - Each60760-767ebaf4ef2-ba38-47ae-b2dd-730180f6d10112023-08-08
60760-767-20EA - Each60760-7678fdb2028-5024-4ae5-a505-c0d9f58166f312023-09-05
60760-767-30EA - Each60760-76737000b32-4c2f-47ca-aa4b-98c88eda089312023-09-05
60760-767-90EA - Each60760-7672d1ed349-7a66-4f04-99b6-6aff61f7ad7f12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-767CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]5Current NDC, 6 package rows20230811_fe81c68d-a579-4fe9-e053-6294a90a7bc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNfe81c68d-a579-4fe9-e053-6294a90a7bc08
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDfe81c68d-a579-4fe9-e053-6294a90a7bc08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-767-04607600767044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-767-04) 2023-06-20NoNoHistorical
60760-767-09607600767099 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-767-09) 2023-08-10NoNoHistorical
60760-767-156076007671515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-767-15) 2023-06-08NoNoHistorical
60760-767-206076007672020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-767-20) 2023-08-01NoNoHistorical
60760-767-306076007673030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-767-30) 2023-08-01NoNoHistorical
60760-767-906076007679090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-767-90) 2023-07-07NoNoHistorical