Orphenadrine Citrate

Product NDC
50090-2438
11-digit product format
500902438
Labeler code
50090
Product ID
50090-2438_acf67e29-5648-48f7-b9d8-b0bad7ffaa69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA040484
Marketing category
ANDA
Marketing start
2006-10-17
Marketing end
0000-00-00
Substance
ORPHENADRINE CITRATE
Active strength
30 mg/mL
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2438-02023-01-30C16284748780-1f386c649-f7d0-0266-e053-dadaa90a7c1aORPHENADRINE CITRATE INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2438-0Orphenadrine Citrate10 in 1 CARTONINJECTION107
50090-2438-0Orphenadrine Citrate2 mL in 1 VIALINJECTION27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2438-0ML - Milliliter50090-2438912f04c3-67b7-4bdc-914f-98e4b4be1c2e12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2438ORPHENADRINE CITRATE INJECTION [A-S MEDICATION SOLUTIONS]7Legacy NDC, 2 package rows20210224_30855838-7757-4533-aff7-b5d1369b0524.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994541orphenadrine citrate 60 MG in 2 ML InjectionPSN30855838-7757-4533-aff7-b5d1369b05247
9945412 ML orphenadrine citrate 30 MG/ML InjectionSCD30855838-7757-4533-aff7-b5d1369b05247
994541orphenadrine citrate 60 MG per 2 ML InjectionSY30855838-7757-4533-aff7-b5d1369b05247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2438-05009024380010 VIAL in 1 CARTON (50090-2438-0) > 2 mL in 1 VIAL10 vial2016-07-270000-00-00NoNoCurrent