Orphenadrine Citrate

Product NDC
33358-274
11-digit product format
333580274
Labeler code
33358
Product ID
33358-274_a5aee68e-8dc7-4e03-af71-3a27f7508098
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RxChange Co.
Application
ANDA040284
Marketing category
ANDA
Marketing start
2014-11-15
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33358-274-602020-01-31C16284748780-19d75b9d0-9325-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-274-60Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-274-60EA - Each33358-27436369b69-e0b6-457f-b7ef-7a9d761abe6f12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORPHENADRINE CITRATEACTIVE INGREDIENTX0A40N8I4SORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]2
ORPHENADRINEACTIVE MOIETYAL805O9OG9ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-274ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RXCHANGE CO.]2Legacy NDC, 1 package rows20141201_b32eb120-fbc3-4ef0-b418-3d1739130475.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSNb32eb120-fbc3-4ef0-b418-3d17391304752
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCDb32eb120-fbc3-4ef0-b418-3d17391304752
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSYb32eb120-fbc3-4ef0-b418-3d17391304752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-274-603335802746060 in 1 BOTTLEHistorical