FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
50090-5712
11-digit product format
500905712
Labeler code
50090
Product ID
50090-5712_39b5ac79-ad9a-4b68-ac00-f28408f7d31d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
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
50090-5712-12023-02-07C16284748780-1f386c649-f344-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5712-82023-02-07C16284748780-1f386c649-f344-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5712-12023-01-30C16284748780-1f386c649-f344-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP
50090-5712-82023-01-30C16284748780-1f386c649-f344-0266-e053-dadaa90a7c1aCyclobenzaprine hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5712-0Cyclobenzaprine hydrochloride3 in 1 BOTTLETABLET, FILM COATED38
50090-5712-1Cyclobenzaprine hydrochloride12 in 1 BOTTLETABLET, FILM COATED128
50090-5712-4Cyclobenzaprine hydrochloride42 in 1 BOTTLETABLET, FILM COATED428
50090-5712-8Cyclobenzaprine hydrochloride6 in 1 BOTTLETABLET, FILM COATED68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5712-1EA - Each50090-5712fca9037e-85c7-4e2b-afbb-bb1183b6412c12022-08-04
50090-5712-4EA - Each50090-571281bf52bd-61ba-4383-b431-c57488fdce5a12024-06-10
50090-5712-8EA - Each50090-571297922bf0-bfa6-4775-885b-13cd488fc76a12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5712CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 4 package rows20240521_bf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNbf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba8
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDbf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5712-0500905712003 TABLET, FILM COATED in 1 BOTTLE (50090-5712-0) 2021-09-24NoNoCurrent
50090-5712-15009057120112 TABLET, FILM COATED in 1 BOTTLE (50090-5712-1) 2021-09-240000-00-00NoNoCurrent
50090-5712-45009057120442 TABLET, FILM COATED in 1 BOTTLE (50090-5712-4) 2021-09-24NoNoCurrent
50090-5712-8500905712086 TABLET, FILM COATED in 1 BOTTLE (50090-5712-8) 2021-09-240000-00-00NoNoCurrent