FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
68071-2471
11-digit product format
680712471
Labeler code
68071
Product ID
68071-2471_136a6ad3-3965-ca75-e063-6394a90a15f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
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
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2471-12024-01-15C16284748780-1f386c64a-32e7-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
68071-2471-92024-01-15C16284748780-1f386c64a-32e7-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
68071-2471-12023-01-30C16284748780-1f386c64a-32e7-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
68071-2471-92023-01-30C16284748780-1f386c64a-32e7-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2471-1Cyclobenzaprine hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
68071-2471-2Cyclobenzaprine hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
68071-2471-7Cyclobenzaprine hydrochloride21 in 1 BOTTLETABLET, FILM COATED213
68071-2471-9Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2471CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 4 package rows20240313_c68d17e2-2311-8e17-e053-2995a90a565b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNc68d17e2-2311-8e17-e053-2995a90a565b3
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDc68d17e2-2311-8e17-e053-2995a90a565b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2471-16807124710115 TABLET, FILM COATED in 1 BOTTLE (68071-2471-1) 2021-07-070000-00-00NoNoCurrent
68071-2471-26807124710220 TABLET, FILM COATED in 1 BOTTLE (68071-2471-2) 2021-07-07NoNoCurrent
68071-2471-76807124710721 TABLET, FILM COATED in 1 BOTTLE (68071-2471-7) 2024-03-11NoNoCurrent
68071-2471-96807124710990 TABLET, FILM COATED in 1 BOTTLE (68071-2471-9) 2021-07-070000-00-00NoNoCurrent