FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
60760-766
11-digit product format
607600766
Labeler code
60760
Product ID
60760-766_52465554-8bbf-6ffa-e063-6394a90a87cf
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
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320

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
60760-766-04CYCLOBENZAPRINE HYDROCHLORIDE4 in 1 BOTTLE, PLASTICTABLET, FILM COATED44
60760-766-15CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED154
60760-766-30CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
60760-766-90CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-766-04EA - Each60760-76659a75015-c544-41d8-a7c2-4be0565f35d912023-08-08
60760-766-15EA - Each60760-766f8955ba6-fe69-49f6-a654-9f5d961ada4812023-08-08
60760-766-30EA - Each60760-7667938f58e-5ea9-4d5a-b399-4042b2ddb5d212023-08-08
60760-766-90EA - Each60760-766304f4062-a8c0-499c-b4e5-4ce73bcbfc9612024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-766CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, 4 package rows20231108_00b20a8c-debd-e930-e063-6394a90a7ed0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN00b20a8c-debd-e930-e063-6394a90a7ed04
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD00b20a8c-debd-e930-e063-6394a90a7ed04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-766-04607600766044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-766-04) 2023-06-29NoNoCurrent
60760-766-156076007661515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-766-15) 2023-06-29NoNoCurrent
60760-766-306076007663030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-766-30) 2017-05-31NoNoCurrent
60760-766-906076007669090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-766-90) 2023-11-01NoNoCurrent