FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
69420-1001
11-digit product format
694201001
Labeler code
69420
Product ID
69420-1001_e28f3c02-e3b3-44e6-895e-40f161d383c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SA3, LLC
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
7.5 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 HYDROCHLORIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299

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
69420-1001-12022-02-18C16284748780-1d6a99b39-95fd-a426-e053-dadaa90af4c2CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-22022-02-18C16284748780-1d6a99b39-95fd-a426-e053-dadaa90af4c2CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-32022-02-18C16284748780-1d6a99b39-95fd-a426-e053-dadaa90af4c2CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-12022-01-28C16284748780-1d6a99b39-95fd-a426-e053-dadaa90af4c2CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-22022-01-28C16284748780-1d6a99b39-95fd-a426-e053-dadaa90af4c2CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-32022-01-28C16284748780-1d6a99b39-95fd-a426-e053-dadaa90af4c2CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69420-1001-1Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10008
69420-1001-2Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
69420-1001-3Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69420-1001-1EA - Each69420-1001e6ea69a7-5e27-4f6a-a746-14512576dd4812015-05-05
69420-1001-2EA - Each69420-10012f4ecc40-7956-4cca-9600-72c4ab2186b412020-02-13
69420-1001-3EA - Each69420-1001ba51461b-7957-4db7-8540-c071baa5269f12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69420-1001CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]7Current NDC, Legacy NDC, 3 package rows20220219_a4ae481f-9e47-470a-b4d1-5a33c0df8761.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNa4cc7965-2ba8-42e8-8c5c-b90145a6598a12
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN794d350b-6c88-41d5-b68b-3e2c57ee2a4f12
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDa4cc7965-2ba8-42e8-8c5c-b90145a6598a12
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD794d350b-6c88-41d5-b68b-3e2c57ee2a4f12
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN59f31ca3-1b28-4768-bb29-520f06f4a9f511
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN81917fa4-c79c-46e2-bfbb-507fc0d7ed1b11
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD59f31ca3-1b28-4768-bb29-520f06f4a9f511
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD81917fa4-c79c-46e2-bfbb-507fc0d7ed1b11
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNb062cb80-79a9-c5d8-e053-2a95a90aecfc8
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNa4ae481f-9e47-470a-b4d1-5a33c0df87618
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDb062cb80-79a9-c5d8-e053-2a95a90aecfc8
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDa4ae481f-9e47-470a-b4d1-5a33c0df87618
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNae3a3f5c-fb64-4a43-be88-a2fc7c298ac16
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDae3a3f5c-fb64-4a43-be88-a2fc7c298ac16
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN903e3a5a-7c58-b70d-e053-2a95a90a6f9d5
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD903e3a5a-7c58-b70d-e053-2a95a90a6f9d5
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN07e3ec53-f1f2-4231-aec6-1772a146ba884
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD07e3ec53-f1f2-4231-aec6-1772a146ba884
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN492392c0-682f-2131-e054-00144ff8d46c3
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD492392c0-682f-2131-e054-00144ff8d46c3
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN81e02f60-2f10-4368-ad1b-e628f00169752
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN48d950cf-dd93-4333-90eb-f519b9590de32
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN3a397e88-d267-feed-e063-6294a90a77102
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNded16433-2462-4fec-8de7-2aed82f55f402
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD81e02f60-2f10-4368-ad1b-e628f00169752
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD48d950cf-dd93-4333-90eb-f519b9590de32
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD3a397e88-d267-feed-e063-6294a90a77102
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDded16433-2462-4fec-8de7-2aed82f55f402
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN7d34c867-7857-480f-b91d-674b49b248b31
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD7d34c867-7857-480f-b91d-674b49b248b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69420-1001-1694201001011000 TABLET, FILM COATED in 1 BOTTLE (69420-1001-1) 2015-03-250000-00-00NoNoCurrent
69420-1001-269420100102100 TABLET, FILM COATED in 1 BOTTLE (69420-1001-2) 2015-03-250000-00-00NoNoCurrent
69420-1001-36942010010330 TABLET, FILM COATED in 1 BOTTLE (69420-1001-3) 2015-03-250000-00-00NoNoCurrent