Orphenadrine Citrate

Product NDC
45865-363
11-digit product format
458650363
Labeler code
45865
Product ID
45865-363_1d38a57b-9470-0776-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA040327
Marketing category
ANDA
Marketing start
2000-02-15
Marketing end
0000-00-00
Substance
ORPHENADRINE CITRATE
Active strength
100 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-363-30Orphenadrine Citrate30 in 1 BOTTLETABLET301
45865-363-49Orphenadrine Citrate100 in 1 BOTTLETABLET1001
45865-363-60Orphenadrine Citrate60 in 1 BOTTLETABLET601
45865-363-90Orphenadrine Citrate90 in 1 BOTTLETABLET901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORPHENADRINE CITRATEACTIVE INGREDIENTX0A40N8I4SORPHENADRINE CITRATE TABLET [MEDSOURCE PHARMACEUTICALS]1
ORPHENADRINEACTIVE MOIETYAL805O9OG9ORPHENADRINE CITRATE TABLET [MEDSOURCE PHARMACEUTICALS]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LORPHENADRINE CITRATE TABLET [MEDSOURCE PHARMACEUTICALS]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BORPHENADRINE CITRATE TABLET [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XORPHENADRINE CITRATE TABLET [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-363ORPHENADRINE CITRATE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 4 package rows20150814_1d38a57b-946f-0776-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN1d38a57b-946f-0776-e054-00144ff8d46c1
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD1d38a57b-946f-0776-e054-00144ff8d46c1
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY1d38a57b-946f-0776-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-363-304586503633030 in 1 BOTTLEHistorical
45865-363-4945865036349100 in 1 BOTTLEHistorical
45865-363-604586503636060 in 1 BOTTLEHistorical
45865-363-904586503639090 in 1 BOTTLEHistorical