Orphenadrine Citrate

Product NDC
10544-283
11-digit product format
105440283
Labeler code
10544
Product ID
10544-283_11a33d71-ca39-2da0-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040284
Marketing category
ANDA
Marketing start
2011-08-10
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
10544-283-202020-01-31C16284748780-19d75b9d0-0286-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-283-20Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-283-20EA - Each10544-283ba5ab268-21e0-4781-9efb-56c44611c28d12015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-283ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150319_11a33d71-ca38-2da0-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN11a33d71-ca38-2da0-e054-00144ff8d46c1
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD11a33d71-ca38-2da0-e054-00144ff8d46c1
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY11a33d71-ca38-2da0-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-283-201054402832020 in 1 BOTTLEHistorical