FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
70518-3474
11-digit product format
705183474
Labeler code
70518
Product ID
70518-3474_4f1afac0-e03f-256f-e063-6394a90ac5d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078643
Marketing category
ANDA
Marketing start
2022-08-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3474-0Cyclobenzaprine Hydrochloride100 in 1 BOXTABLET, FILM COATED10013
70518-3474-1Cyclobenzaprine Hydrochloride1 in 1 POUCHTABLET, FILM COATED113
70518-3474-2Cyclobenzaprine Hydrochloride5 in 1 BOTTLE, PLASTICTABLET, FILM COATED513
70518-3474-3Cyclobenzaprine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED613
70518-3474-4Cyclobenzaprine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6013
70518-3474-5Cyclobenzaprine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1513
70518-3474-6Cyclobenzaprine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10013
70518-3474-7Cyclobenzaprine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2013
70518-3474-8Cyclobenzaprine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-3474-9Cyclobenzaprine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3474-8EA - Each70518-34743c1f5d06-642d-41c1-ad8c-aca5302bfddb12026-01-08
70518-3474-9EA - Each70518-3474f98b72c0-57fe-4c9f-a3be-7ff4f77b764a12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3474CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 10 package rows20241213_b09ca979-ab6b-441b-a66f-41ca32eae6cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNb09ca979-ab6b-441b-a66f-41ca32eae6cb13
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDb09ca979-ab6b-441b-a66f-41ca32eae6cb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3474-070518347400100 POUCH in 1 BOX (70518-3474-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3474-1) 100 pouch2022-08-090000-00-00NoNoCurrent
70518-3474-1705183474011 in 1 POUCHHistorical
70518-3474-2705183474025 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-2) 2022-08-130000-00-00NoNoCurrent
70518-3474-3705183474036 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-3) 2022-08-170000-00-00NoNoCurrent
70518-3474-47051834740460 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-4) 2022-08-230000-00-00NoNoCurrent
70518-3474-57051834740515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-5) 2022-08-230000-00-00NoNoCurrent
70518-3474-670518347406100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-6) 2022-09-050000-00-00NoNoCurrent
70518-3474-77051834740720 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-7) 2022-09-290000-00-00NoNoCurrent
70518-3474-87051834740890 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-8) 2022-11-090000-00-00NoNoCurrent
70518-3474-97051834740930 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-9) 2022-12-010000-00-00NoNoCurrent