FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
51655-427
11-digit product format
516550427
Labeler code
51655
Product ID
51655-427_490ec87f-5dd5-d491-e063-6294a90aff60
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
2020-09-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-427-262023-03-27C16284748780-1f386c64a-2920-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
51655-427-532023-03-27C16284748780-1f386c64a-2920-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
51655-427-262023-01-30C16284748780-1f386c64a-2920-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
51655-427-532023-01-30C16284748780-1f386c64a-2920-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-427-26CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
51655-427-52CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
51655-427-53CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-427CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 3 package rows20230328_c29cf8bd-2f63-ed4b-e053-2995a90ab6eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNc29cf8bd-2f63-ed4b-e053-2995a90ab6eb3
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDc29cf8bd-2f63-ed4b-e053-2995a90ab6eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-427-265165504272690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-427-26) 2021-04-010000-00-00NoNoCurrent
51655-427-525165504275230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-427-52) 2022-04-13NoNoHistorical
51655-427-535165504275310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-427-53) 2020-09-010000-00-00NoNoCurrent