FDA.reportPublic FDA data

CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
50090-4729
11-digit product format
500904729
Labeler code
50090
Product ID
50090-4729_44f75da3-1fee-4928-b8eb-491d47d8bc08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208170
Marketing category
ANDA
Marketing start
2017-05-31
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
Rxcui828348

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
50090-4729-12023-02-07C16284748780-1f386c649-c04d-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4729-82023-02-07C16284748780-1f386c649-c04d-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4729-12023-01-30C16284748780-1f386c649-c04d-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP
50090-4729-82023-01-30C16284748780-1f386c649-c04d-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4729-0CYCLOBENZAPRINE HYDROCHLORIDE3 in 1 BOTTLETABLET, FILM COATED36
50090-4729-1CYCLOBENZAPRINE HYDROCHLORIDE12 in 1 BOTTLETABLET, FILM COATED126
50090-4729-4CYCLOBENZAPRINE HYDROCHLORIDE42 in 1 BOTTLETABLET, FILM COATED426
50090-4729-8CYCLOBENZAPRINE HYDROCHLORIDE6 in 1 BOTTLETABLET, FILM COATED66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4729-1EA - Each50090-4729531ed79c-df86-4156-992d-91e08ba6377a12024-06-10
50090-4729-4EA - Each50090-47298856f094-f586-4491-ae7a-6eda97d1618c12024-06-10
50090-4729-8EA - Each50090-4729a3330ca9-2f50-4b59-99ba-ee85b44816bf12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4729CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 4 package rows20240531_d64ca498-81c6-4e10-ba82-3a50ee47bcfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNd64ca498-81c6-4e10-ba82-3a50ee47bcfc6
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDd64ca498-81c6-4e10-ba82-3a50ee47bcfc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4729-0500904729003 TABLET, FILM COATED in 1 BOTTLE (50090-4729-0) 2019-11-18NoNoCurrent
50090-4729-15009047290112 TABLET, FILM COATED in 1 BOTTLE (50090-4729-1) 2019-11-180000-00-00NoNoCurrent
50090-4729-45009047290442 TABLET, FILM COATED in 1 BOTTLE (50090-4729-4) 2019-11-18NoNoCurrent
50090-4729-8500904729086 TABLET, FILM COATED in 1 BOTTLE (50090-4729-8) 2019-11-180000-00-00NoNoCurrent