FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
69097-845
11-digit product format
690970845
Labeler code
69097
Product ID
69097-845_0e5c376d-9599-4825-9226-016d40cf6113
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA090478
Marketing category
ANDA
Marketing start
2016-07-22
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, 828348

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
69097-845-07Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
69097-845-15Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-845CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [CIPLA USA INC.]4Current NDC, Legacy NDC, 2 package rows20210316_575a31fb-04c5-4001-88a7-c33adbacc6a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSN64f6d1be-4067-a5c7-2343-4aed651a0cac10
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD64f6d1be-4067-a5c7-2343-4aed651a0cac10
828320cyclobenzaprine HCl 5 MG Oral TabletPSN91dae210-b0fb-44d5-93c2-8295c1d196069
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD91dae210-b0fb-44d5-93c2-8295c1d196069
828320cyclobenzaprine HCl 5 MG Oral TabletPSN273e36cd-5ab7-49e5-934f-8a23df24e0606
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD273e36cd-5ab7-49e5-934f-8a23df24e0606
828348cyclobenzaprine HCl 10 MG Oral TabletPSN575a31fb-04c5-4001-88a7-c33adbacc6a84
828320cyclobenzaprine HCl 5 MG Oral TabletPSN575a31fb-04c5-4001-88a7-c33adbacc6a84
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD575a31fb-04c5-4001-88a7-c33adbacc6a84
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD575a31fb-04c5-4001-88a7-c33adbacc6a84
828348cyclobenzaprine HCl 10 MG Oral TabletPSN43cc254b-6633-63dd-e054-00144ff88e883
828320cyclobenzaprine HCl 5 MG Oral TabletPSN43cc254b-6633-63dd-e054-00144ff88e883
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD43cc254b-6633-63dd-e054-00144ff88e883
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD43cc254b-6633-63dd-e054-00144ff88e883
828320cyclobenzaprine HCl 5 MG Oral TabletPSN9718d17f-9c78-292a-e053-2a95a90a38c32
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD9718d17f-9c78-292a-e053-2a95a90a38c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-845-0769097084507100 TABLET, FILM COATED in 1 BOTTLE (69097-845-07) 2016-07-220000-00-00NoNoCurrent
69097-845-15690970845151000 TABLET, FILM COATED in 1 BOTTLE (69097-845-15) 2016-07-220000-00-00NoNoCurrent