FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
10544-159
11-digit product format
105440159
Labeler code
10544
Product ID
10544-159_df94605b-0121-4285-8b97-7aa349c28d93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA078218
Marketing category
ANDA
Marketing start
2010-01-25
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-159-092019-10-21C16284748780-1956f9ecf-cb7c-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets, USP
10544-159-152019-10-21C16284748780-1956f9ecf-cb7c-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets, USP
10544-159-202019-10-21C16284748780-1956f9ecf-cb7c-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets, USP
10544-159-302019-10-21C16284748780-1956f9ecf-cb7c-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets, USP
10544-159-602019-10-21C16284748780-1956f9ecf-cb7c-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets, USP
10544-159-902019-10-21C16284748780-1956f9ecf-cb7c-621f-e053-dbdaa90a74adCyclobenzaprine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-159-09Cyclobenzaprine Hydrochloride9 in 1 BOTTLETABLET91
10544-159-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET151
10544-159-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET201
10544-159-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET301
10544-159-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET601
10544-159-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-159-09EA - Each10544-159c8f1e00a-ee31-4bc9-945b-79b4d62d407012015-02-02
10544-159-15EA - Each10544-1598a47552c-8552-4f00-88c9-47f11bee43a912015-02-02
10544-159-20EA - Each10544-1593c94f8b0-fd13-4c47-bdc0-19f5ce58daf412015-02-02
10544-159-30EA - Each10544-15939ed45a7-3aef-40c9-9c9e-d30be701223412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-159CYCLOBENZAPRINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 6 package rows20100421_f4fee702-2561-4317-b219-23d4543f2c75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf4fee702-2561-4317-b219-23d4543f2c751
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf4fee702-2561-4317-b219-23d4543f2c751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-159-09105440159099 in 1 BOTTLEHistorical
10544-159-151054401591515 in 1 BOTTLEHistorical
10544-159-201054401592020 in 1 BOTTLEHistorical
10544-159-301054401593030 in 1 BOTTLEHistorical
10544-159-601054401596060 in 1 BOTTLEHistorical
10544-159-901054401599090 in 1 BOTTLEHistorical