FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
51655-592
11-digit product format
516550592
Labeler code
51655
Product ID
51655-592_49612fd2-0c18-42a0-e063-6394a90a00fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA208170
Marketing category
ANDA
Marketing start
2023-01-03
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
51655-592-20CYCLOBENZAPRINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET, FILM COATED203
51655-592-25CYCLOBENZAPRINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603
51655-592-26CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
51655-592-52CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
51655-592-53CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
51655-592-54CYCLOBENZAPRINE HYDROCHLORIDE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-592CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 6 package rows20230701_f32bceda-1d24-322d-e053-2995a90aae1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf32bceda-1d24-322d-e053-2995a90aae1b3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf32bceda-1d24-322d-e053-2995a90aae1b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-592-205165505922020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-592-20) 2023-01-31NoNoCurrent
51655-592-255165505922560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-592-25) 2023-05-02NoNoCurrent
51655-592-265165505922690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-592-26) 2023-02-07NoNoCurrent
51655-592-525165505925230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-592-52) 2023-01-03NoNoCurrent
51655-592-535165505925310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-592-53) 2023-01-03NoNoCurrent
51655-592-545165505925415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-592-54) 2023-01-03NoNoCurrent