FDA.reportPublic FDA data

Orphenadrine Citrate

Product NDC
68788-9138
11-digit product format
687889138
Labeler code
68788
Product ID
68788-9138_0352ec7a-81c3-46fb-a72d-3283c64acec8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA040284
Marketing category
ANDA
Marketing start
1998-06-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orphenadrine Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ORPHENADRINE CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0A40N8I4S
Rxcui994521

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9138-1Orphenadrine Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE10013
68788-9138-2Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE2013
68788-9138-3Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE3013
68788-9138-4Orphenadrine Citrate14 in 1 BOTTLETABLET, EXTENDED RELEASE1413
68788-9138-6Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE6013
68788-9138-8Orphenadrine Citrate120 in 1 BOTTLETABLET, EXTENDED RELEASE12013
68788-9138-9Orphenadrine Citrate90 in 1 BOTTLETABLET, EXTENDED RELEASE9013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORPHENADRINE CITRATEACTIVE INGREDIENTX0A40N8I4SORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]3
ORPHENADRINEACTIVE MOIETYAL805O9OG9ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9138ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 7 package rows20240726_8ca9438d-320f-4499-aee7-6b8ca7cccc65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN8ca9438d-320f-4499-aee7-6b8ca7cccc6513
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD8ca9438d-320f-4499-aee7-6b8ca7cccc6513
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY8ca9438d-320f-4499-aee7-6b8ca7cccc6513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-9138-168788913801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-1) 2011-11-220000-00-00NoNoCurrent
68788-9138-26878891380220 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-2) 2011-11-220000-00-00NoNoCurrent
68788-9138-36878891380330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-3) 2011-11-220000-00-00NoNoCurrent
68788-9138-46878891380414 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-4) 2011-11-220000-00-00NoNoCurrent
68788-9138-66878891380660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-6) 2011-11-220000-00-00NoNoCurrent
68788-9138-868788913808120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-8) 2011-11-220000-00-00NoNoCurrent
68788-9138-96878891380990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-9) 2011-11-220000-00-00NoNoCurrent