FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
51655-818
11-digit product format
516550818
Labeler code
51655
Product ID
51655-818_4a7cdbd9-9b31-94f5-e063-6394a90ac9c9
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
2023-01-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-818-262026-01-29C16284748780-149896155-a38c-586f-e063-e6dba90add90Cyclobenzaprine hydrochloride, USP
51655-818-522026-01-29C16284748780-149896155-a38c-586f-e063-e6dba90add90Cyclobenzaprine hydrochloride, USP
51655-818-532026-01-29C16284748780-149896155-a38c-586f-e063-e6dba90add90Cyclobenzaprine hydrochloride, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-818-26CYCLOBENZAPRINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED903
51655-818-52CYCLOBENZAPRINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303
51655-818-53CYCLOBENZAPRINE HYDROCHLORIDE10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-818CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 3 package rows20231114_f708cf0f-8373-14a2-e053-6394a90ab3fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf708cf0f-8373-14a2-e053-6394a90ab3fe3
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf708cf0f-8373-14a2-e053-6394a90ab3fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-818-265165508182690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-818-26) 2023-01-31NoNoHistorical
51655-818-525165508185230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-818-52) 2023-02-28NoNoHistorical
51655-818-535165508185310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-818-53) 2023-08-24NoNoHistorical