FDA.reportPublic FDA data

AMRIX

Product NDC
21695-953
11-digit product format
216950953
Labeler code
21695
Product ID
21695-953_087ae128-1a5d-406e-8bd3-15cb640f6922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021777
Marketing category
NDA
Marketing start
2007-10-01
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-953-602019-09-24C16284748780-1934fe258-4d4c-48b1-e053-8cdaa90a720aAMRIX ® (Cyclobenzaprine Hydrochloride Extended-Release Capsules)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-953-60AMRIX60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-953-60EA - Each21695-95357310873-497f-4071-81a7-d031debc138c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cyclobenzaprine hydrochlorideACTIVE INGREDIENT0VE05JYS2PAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
CyclobenzaprineACTIVE MOIETY69O5WQQ5TIAMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-953AMRIX (CYCLOBENZAPRINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20111216_087ae128-1a5d-406e-8bd3-15cb640f6922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828355Amrix 30 MG 24HR Extended Release Oral CapsulePSN087ae128-1a5d-406e-8bd3-15cb640f69221
828353cyclobenzaprine HCl 30 MG 24HR Extended Release Oral CapsulePSN087ae128-1a5d-406e-8bd3-15cb640f69221
82835524 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule [Amrix]SBD087ae128-1a5d-406e-8bd3-15cb640f69221
82835324 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral CapsuleSCD087ae128-1a5d-406e-8bd3-15cb640f69221
82835524 HR Amrix 30 MG Extended Release Oral CapsuleSY087ae128-1a5d-406e-8bd3-15cb640f69221
828355Amrix 30 MG 24 HR Extended Release Oral CapsuleSY087ae128-1a5d-406e-8bd3-15cb640f69221
828353cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral CapsuleSY087ae128-1a5d-406e-8bd3-15cb640f69221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-953-602169509536060 in 1 BOTTLEHistorical