FDA.reportPublic FDA data

Orphenadrine Citrate

Product NDC
52959-527
11-digit product format
529590527
Labeler code
52959
Product ID
52959-527_2637a5d7-26be-4a9b-ad46-b9d96d929e3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA040368
Marketing category
ANDA
Marketing start
2000-06-23
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
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-527-102020-01-31C16284748780-19d75b9d0-d3a8-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-release Tablets, 100 mg
52959-527-142020-01-31C16284748780-19d75b9d0-d3a8-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-release Tablets, 100 mg
52959-527-202020-01-31C16284748780-19d75b9d0-d3a8-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-release Tablets, 100 mg
52959-527-302020-01-31C16284748780-19d75b9d0-d3a8-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-release Tablets, 100 mg
52959-527-602020-01-31C16284748780-19d75b9d0-d3a8-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-release Tablets, 100 mg
52959-527-902020-01-31C16284748780-19d75b9d0-d3a8-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-release Tablets, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-527-10Orphenadrine Citrate10 in 1 BOTTLETABLET, EXTENDED RELEASE102
52959-527-14Orphenadrine Citrate14 in 1 BOTTLETABLET, EXTENDED RELEASE142
52959-527-20Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE202
52959-527-30Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE302
52959-527-60Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE602
52959-527-90Orphenadrine Citrate90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-527-10EA - Each52959-52742b88514-f937-4c1b-9e22-cf74e1cb704a12012-07-24
52959-527-14EA - Each52959-527add12ddc-ca2d-43f6-b6cb-64b0375083e512012-07-24
52959-527-20EA - Each52959-527c835b43e-6d88-44d0-ba3c-95509edd166212012-07-24
52959-527-30EA - Each52959-5276d4348b3-8a41-413a-aa6e-36ca591a6cb912012-07-24
52959-527-60EA - Each52959-5275ecc9ff4-4e0c-4866-a231-d38813698dfe12012-07-24
52959-527-90EA - Each52959-527216657d1-f5e2-4c0c-a749-35f25f21f52012015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORPHENADRINE CITRATEACTIVE INGREDIENTX0A40N8I4SORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
ORPHENADRINEACTIVE MOIETYAL805O9OG9ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-527ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 6 package rows20110826_b0a4eb39-ec35-4e60-99c2-422ef5287585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSNb0a4eb39-ec35-4e60-99c2-422ef52875852
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCDb0a4eb39-ec35-4e60-99c2-422ef52875852
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSYb0a4eb39-ec35-4e60-99c2-422ef52875852

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-527-105295905271010 in 1 BOTTLEHistorical
52959-527-145295905271414 in 1 BOTTLEHistorical
52959-527-205295905272020 in 1 BOTTLEHistorical
52959-527-305295905273030 in 1 BOTTLEHistorical
52959-527-605295905276060 in 1 BOTTLEHistorical
52959-527-905295905279090 in 1 BOTTLEHistorical