FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
21695-037
11-digit product format
216950037
Labeler code
21695
Product ID
21695-037_3290187a-7eb6-4067-ac9e-fc8dfc722e0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-037-002019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-102019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-122019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-142019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-152019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-202019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-212019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-302019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-452019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-602019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP
21695-037-902019-09-24C16284748780-1934fe258-4947-48b1-e053-8cdaa90a720aCyclobenzaprine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-037-00Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET1001
21695-037-10Cyclobenzaprine Hydrochloride10 in 1 BOTTLETABLET101
21695-037-12Cyclobenzaprine Hydrochloride12 in 1 BOTTLETABLET121
21695-037-14Cyclobenzaprine Hydrochloride14 in 1 BOTTLETABLET141
21695-037-15Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET151
21695-037-20Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET201
21695-037-21Cyclobenzaprine Hydrochloride21 in 1 BOTTLETABLET211
21695-037-30Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET301
21695-037-45Cyclobenzaprine Hydrochloride45 in 1 BOTTLETABLET451
21695-037-60Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET601
21695-037-90Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-037-00EA - Each21695-037bdd2ed0f-4501-4b70-bfcc-a12473cef77312012-07-24
21695-037-10EA - Each21695-03794264b01-2f3d-4eff-ab96-33634583cc5412012-07-24
21695-037-12EA - Each21695-0374b9875b6-5828-4e2e-baa7-7affbc5923fe12012-07-24
21695-037-14EA - Each21695-037f87af6dc-5ff6-4964-99d3-9940ceeee0ee12012-07-24
21695-037-15EA - Each21695-037b4cab32d-542f-488a-8b71-ff7ebcab810612012-07-24
21695-037-20EA - Each21695-037a12bce1d-94b8-416b-8853-0f3a6eadb7fa12012-07-24
21695-037-21EA - Each21695-037bf079502-9473-4304-bc93-cb28f506a1be12012-07-24
21695-037-30EA - Each21695-037764d347e-444a-4bb8-867c-f69dad490e6d12012-07-24
21695-037-45EA - Each21695-03725564c22-1017-46b5-97fe-b4c876cfebdd12012-07-24
21695-037-60EA - Each21695-037c52357fb-0a63-4cce-b131-2a4f7669198412012-07-24
21695-037-90EA - Each21695-0378b575b9a-836f-4211-bf03-a1e1ab85ef7612012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-037CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS]1Legacy NDC, 11 package rows20100224_0e185b89-d7cc-477f-ab8c-7c6f44e5c9e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN0e185b89-d7cc-477f-ab8c-7c6f44e5c9e71
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD0e185b89-d7cc-477f-ab8c-7c6f44e5c9e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-037-0021695003700100 in 1 BOTTLEHistorical
21695-037-102169500371010 in 1 BOTTLEHistorical
21695-037-122169500371212 in 1 BOTTLEHistorical
21695-037-142169500371414 in 1 BOTTLEHistorical
21695-037-152169500371515 in 1 BOTTLEHistorical
21695-037-202169500372020 in 1 BOTTLEHistorical
21695-037-212169500372121 in 1 BOTTLEHistorical
21695-037-302169500373030 in 1 BOTTLEHistorical
21695-037-452169500374545 in 1 BOTTLEHistorical
21695-037-602169500376060 in 1 BOTTLEHistorical
21695-037-902169500379090 in 1 BOTTLEHistorical