Cyclobenzaprine Hydrochloride

Product NDC
31722-283
11-digit product format
317220283
Labeler code
31722
Product ID
31722-283_8b931a82-f7b1-4569-aff8-da927068ac39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals
Application
ANDA090478
Marketing category
ANDA
Marketing start
2012-04-02
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
E
Listing certified through
2017-12-31
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-283-01EA - Each31722-283e0201e6d-0c0b-49f5-abcd-0c471ca8840712012-07-24
31722-283-10EA - Each31722-283eee1d170-974b-40bb-8621-846227a0b2bd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]5
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-283CYCLOBENZAPRINE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS]1Legacy NDC20120410_68347db5-9f3d-430e-bd8a-16071077648f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN27327397-3ff7-6e43-e054-00144ff88e885
828348cyclobenzaprine HCl 10 MG Oral TabletPSN5f2c5599-c4cd-47d6-83bb-a7cc1cf70db75
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD27327397-3ff7-6e43-e054-00144ff88e885
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD5f2c5599-c4cd-47d6-83bb-a7cc1cf70db75
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1db200b7-75d2-5e17-e054-00144ff8d46c2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1db200b7-75d2-5e17-e054-00144ff8d46c2