FDA.reportPublic FDA data

Cyclobenzaprine

Product NDC
57237-266
11-digit product format
572370266
Labeler code
57237
Product ID
57237-266_09330886-13f8-44cc-98d2-883f3e0514b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Health, LLC
Application
ANDA071611
Marketing category
ANDA
Marketing start
2016-10-18
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
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-266-01EA - Each57237-266f96bd9d7-9db8-4546-b6e5-4f243db894c512016-11-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSNf40e92bb-c86b-4634-9bba-9fa4616aba825
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCDf40e92bb-c86b-4634-9bba-9fa4616aba825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-266-0157237026601100 TABLET, FILM COATED in 1 BOTTLE (57237-266-01) 2016-10-180000-00-00NoNoCurrent