Cyclobenzaprine Hydrochloride

Product NDC
60429-876
11-digit product format
604290876
Labeler code
60429
Product ID
60429-876_45b42f33-472c-dff2-e063-6394a90a379c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA077797
Marketing category
ANDA
Marketing start
2007-02-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2026-12-31

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
60429-876-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1007
60429-876-05Cyclobenzaprine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-876-01EA - Each60429-87650bacfca-8673-43d2-a632-9da65a3a4fb512017-09-11
60429-876-05EA - Each60429-87644110a84-fcaf-45f0-9a55-77bec781820c12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-876CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]6Current NDC, Legacy NDC, 2 package rows20240822_15c0c7aa-8c54-4040-a1bf-2a7b421ad33f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN15c0c7aa-8c54-4040-a1bf-2a7b421ad33f7
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD15c0c7aa-8c54-4040-a1bf-2a7b421ad33f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-876-0160429087601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-876-01) 2017-04-070000-00-00NoNoCurrent
60429-876-0560429087605500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-876-05) 2017-04-070000-00-00NoNoCurrent