FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
33261-033
11-digit product format
332610033
Labeler code
33261
Product ID
33261-033_1b891b2e-c23a-44cf-8d4e-4d26dd070023
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078218
Marketing category
ANDA
Marketing start
2010-02-18
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-033-022020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-122020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-142020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-152020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-202020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-212020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-302020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-402020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-602020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP
33261-033-902020-01-31C16284748780-19d75b9d0-a24f-f424-e053-dadaa90a57ceCyclobenzaprine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-033-02Cyclobenzaprine Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1201
33261-033-12Cyclobenzaprine Hydrochloride12 in 1 BOTTLE, PLASTICTABLET121
33261-033-14Cyclobenzaprine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET141
33261-033-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET151
33261-033-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET201
33261-033-21Cyclobenzaprine Hydrochloride21 in 1 BOTTLE, PLASTICTABLET211
33261-033-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301
33261-033-40Cyclobenzaprine Hydrochloride40 in 1 BOTTLE, PLASTICTABLET401
33261-033-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET601
33261-033-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-033-02EA - Each33261-033576e2f14-0b2f-44b6-aacd-912315f5d71112015-10-02
33261-033-14EA - Each33261-03336852477-a41b-4bce-ace5-27ebe986022112015-10-02
33261-033-20EA - Each33261-0334899bb8a-1c51-4da3-a9ca-e86c0d20392712015-10-02
33261-033-21EA - Each33261-03389d55901-5e57-43a4-a8d5-684da44de7de12015-10-02
33261-033-30EA - Each33261-0332d87bbf6-853a-48b7-93d6-6cb39e77d22a12015-10-02
33261-033-40EA - Each33261-033aaa12e51-aff8-4ce7-9d82-4cfe270698b212015-10-02
33261-033-60EA - Each33261-03351a6a548-ba40-41a4-89be-137bf0b097bb12015-10-02
33261-033-90EA - Each33261-0334f63d610-41cf-45d8-8bf1-f5746188ab1712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-033CYCLOBENZAPRINE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 10 package rows20140102_c108987e-f1f9-4f0e-893a-fb036af0ce08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNc108987e-f1f9-4f0e-893a-fb036af0ce081
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDc108987e-f1f9-4f0e-893a-fb036af0ce081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-033-0233261003302120 in 1 BOTTLE, PLASTICHistorical
33261-033-123326100331212 in 1 BOTTLE, PLASTICHistorical
33261-033-143326100331414 in 1 BOTTLE, PLASTICHistorical
33261-033-153326100331515 in 1 BOTTLE, PLASTICHistorical
33261-033-203326100332020 in 1 BOTTLE, PLASTICHistorical
33261-033-213326100332121 in 1 BOTTLE, PLASTICHistorical
33261-033-303326100333030 in 1 BOTTLE, PLASTICHistorical
33261-033-403326100334040 in 1 BOTTLE, PLASTICHistorical
33261-033-603326100336060 in 1 BOTTLE, PLASTICHistorical
33261-033-903326100339090 in 1 BOTTLE, PLASTICHistorical