FDA.reportPublic FDA data

Orphenadrine Citrate

Product NDC
50090-3150
11-digit product format
500903150
Labeler code
50090
Product ID
50090-3150_c6e2ac44-d484-4486-8a05-486ef706350d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3150-02023-01-30C16284748780-1f386c649-c21d-0266-e053-dadaa90a7c1aOrphenadrine Citrate Extended-release Tablets, 100 mg
50090-3150-12023-01-30C16284748780-1f386c649-c21d-0266-e053-dadaa90a7c1aOrphenadrine Citrate Extended-release Tablets, 100 mg
50090-3150-22023-01-30C16284748780-1f386c649-c21d-0266-e053-dadaa90a7c1aOrphenadrine Citrate Extended-release Tablets, 100 mg
50090-3150-52023-01-30C16284748780-1f386c649-c21d-0266-e053-dadaa90a7c1aOrphenadrine Citrate Extended-release Tablets, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3150-0Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE207
50090-3150-1Orphenadrine Citrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE307
50090-3150-2Orphenadrine Citrate14 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE147
50090-3150-5Orphenadrine Citrate60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3150-0EA - Each50090-315039361858-83b1-4c0a-8c49-021f3263b9f412018-12-13
50090-3150-1EA - Each50090-31507006f2ac-bfad-482a-8575-fa0816c9335812019-05-02
50090-3150-5EA - Each50090-3150454820d2-a4bf-4ab1-8a40-522baf10f68c12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3150ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 4 package rows20190427_75237fb5-b1bc-479d-97d1-8fad599864b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN75237fb5-b1bc-479d-97d1-8fad599864b87
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD75237fb5-b1bc-479d-97d1-8fad599864b87
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY75237fb5-b1bc-479d-97d1-8fad599864b87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3150-05009031500020 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-3150-0) 2017-10-030000-00-00NoNoCurrent
50090-3150-15009031500130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3150-1) 2014-11-280000-00-00NoNoCurrent
50090-3150-25009031500214 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3150-2) 2014-11-280000-00-00NoNoCurrent
50090-3150-55009031500560 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-3150-5) 2014-11-280000-00-00NoNoCurrent