FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
64980-657
11-digit product format
649800657
Labeler code
64980
Product ID
64980-657_0512aebe-5f3a-4d41-9a41-7c37e001af75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA218936
Marketing category
ANDA
Marketing start
2025-02-19
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
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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828320, 828348

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
64980-657-01Cyclobenzaprine Hydrochloride100 in 1 BOTTLETABLET1001
64980-657-10Cyclobenzaprine Hydrochloride1000 in 1 BOTTLETABLET10001
64980-657-50Cyclobenzaprine Hydrochloride500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-657-01EA - Each64980-657f16a6d90-b9d2-42b1-bf5e-f8e26aceecaa12025-06-13
64980-657-10EA - Each64980-6572cd94df1-fa81-4182-8f0e-b1e4d9ec059512025-06-13
64980-657-50EA - Each64980-657a29a246c-126b-4639-b996-6b6682ef837012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-657CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 3 package rows20250223_6018b6e9-938d-4fc9-86d7-1fd1d7bfcc58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN6018b6e9-938d-4fc9-86d7-1fd1d7bfcc581
828348cyclobenzaprine HCl 10 MG Oral TabletPSN6536b470-9a4e-4174-85b8-479f64cc32961
828320cyclobenzaprine HCl 5 MG Oral TabletPSN6018b6e9-938d-4fc9-86d7-1fd1d7bfcc581
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD6018b6e9-938d-4fc9-86d7-1fd1d7bfcc581
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD6536b470-9a4e-4174-85b8-479f64cc32961
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD6018b6e9-938d-4fc9-86d7-1fd1d7bfcc581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-657-0164980065701100 TABLET in 1 BOTTLE (64980-657-01) 100 tablet2025-02-19NoNoCurrent
64980-657-10649800657101000 TABLET in 1 BOTTLE (64980-657-10) 1000 tablet2025-02-19NoNoCurrent
64980-657-5064980065750500 TABLET in 1 BOTTLE (64980-657-50) 500 tablet2025-02-19NoNoCurrent