FDA.reportPublic FDA data

Cyclobenzaprine Hydrochloride

Product NDC
50436-1101
11-digit product format
504361101
Labeler code
50436
Product ID
50436-1101_00d81aff-ba3f-4506-a651-23eba0183ab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078722
Marketing category
ANDA
Marketing start
2015-03-25
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
2022-12-31
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
50436-1101-12023-01-30C16284748780-1f386c64a-0bd7-0266-e053-dadaa90a7c1aCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
50436-1101-22023-01-30C16284748780-1f386c64a-0bd7-0266-e053-dadaa90a7c1aCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
50436-1101-32023-01-30C16284748780-1f386c64a-0bd7-0266-e053-dadaa90a7c1aCYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-1101-1Cyclobenzaprine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
50436-1101-2Cyclobenzaprine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
50436-1101-3Cyclobenzaprine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-1101-1EA - Each50436-11016e5a65cf-4d98-4368-8e11-2f45c3e99f1012021-12-08
50436-1101-2EA - Each50436-11015e1744ca-5bc2-487d-ab27-e2b8a347914f12021-12-08
50436-1101-3EA - Each50436-11013674ea7c-ee4a-4a49-a762-35bacb960d4a12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1101CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20211023_81e02f60-2f10-4368-ad1b-e628f0016975.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN81e02f60-2f10-4368-ad1b-e628f00169752
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD81e02f60-2f10-4368-ad1b-e628f00169752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-1101-15043611010130 TABLET, FILM COATED in 1 BOTTLE (50436-1101-1) 2021-10-120000-00-00NoNoCurrent
50436-1101-25043611010260 TABLET, FILM COATED in 1 BOTTLE (50436-1101-2) 2021-10-120000-00-00NoNoCurrent
50436-1101-35043611010390 TABLET, FILM COATED in 1 BOTTLE (50436-1101-3) 2021-10-120000-00-00NoNoCurrent