FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
70518-3251
11-digit product format
705183251
Labeler code
70518
Product ID
70518-3251_4edebb66-8e7b-1fe6-e063-6394a90a7ec6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213324
Marketing category
ANDA
Marketing start
2021-10-20
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320

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
70518-3251-0Cyclobenzaprine hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013
70518-3251-1Cyclobenzaprine hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3013
70518-3251-2Cyclobenzaprine hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-3251-3Cyclobenzaprine hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6013
70518-3251-4Cyclobenzaprine hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2013
70518-3251-5Cyclobenzaprine hydrochloride120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12013
70518-3251-6Cyclobenzaprine hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3251-1EA - Each70518-325123561a09-32c1-4646-aa15-937e819dcb6312026-02-05
70518-3251-2EA - Each70518-32519ec5d28c-2939-4990-b7dc-e38801b30ea512026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3251CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 7 package rows20240929_eb2b24b1-2851-440f-9075-b6a123a1fd5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828320cyclobenzaprine HCl 5 MG Oral TabletPSNeb2b24b1-2851-440f-9075-b6a123a1fd5c13
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDeb2b24b1-2851-440f-9075-b6a123a1fd5c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3251-07051832510090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3251-0) 2021-10-200000-00-00NoNoCurrent
70518-3251-17051832510130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3251-1) 2021-11-160000-00-00NoNoCurrent
70518-3251-27051832510230 TABLET, FILM COATED in 1 BLISTER PACK (70518-3251-2) 2021-11-230000-00-00NoNoCurrent
70518-3251-37051832510360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3251-3) 2021-12-200000-00-00NoNoCurrent
70518-3251-47051832510420 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3251-4) 2022-06-020000-00-00NoNoCurrent
70518-3251-570518325105120 in 1 BOTTLE, PLASTICHistorical
70518-3251-67051832510615 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3251-6) 2025-06-09NoNoCurrent