CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
68071-2880
11-digit product format
680712880
Labeler code
68071
Product ID
68071-2880_edb1e8e3-6387-7976-e053-2a95a90a11cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
68071-2880-12025-01-30C16284748780-12cef2736-7a8f-d83d-e063-dadaa90ab31fCyclobenzaprine hydrochloride, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2880-1CYCLOBENZAPRINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2880CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221118_edb1e8e3-6388-7976-e053-2a95a90a11cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNedb1e8e3-6388-7976-e053-2a95a90a11cd1
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDedb1e8e3-6388-7976-e053-2a95a90a11cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2880-168071288001100 TABLET, FILM COATED in 1 BOTTLE (68071-2880-1) 2022-11-170000-00-00NoNoCurrent