FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
51655-973
11-digit product format
516550973
Labeler code
51655
Product ID
51655-973_4960a71d-10d7-6f03-e063-6394a90a710f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090478
Marketing category
ANDA
Marketing start
2022-05-04
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
51655-973-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED203
51655-973-25Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603
51655-973-52Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
51655-973-53Cyclobenzaprine Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
51655-973-54Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153
51655-973-87Cyclobenzaprine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-973CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 6 package rows20230404_e04eea45-12ec-4d2b-e053-2a95a90a6b76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNe04eea45-12ec-4d2b-e053-2a95a90a6b763
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDe04eea45-12ec-4d2b-e053-2a95a90a6b763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-973-205165509732020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-20) 2022-10-17NoNoCurrent
51655-973-255165509732560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-25) 2022-09-06NoNoCurrent
51655-973-525165509735230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-52) 2022-10-07NoNoCurrent
51655-973-535165509735310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-53) 2022-07-27NoNoCurrent
51655-973-545165509735415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-54) 2022-08-24NoNoCurrent
51655-973-87516550973876 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-87) 2022-05-040000-00-00NoNoCurrent