FDA.reportPublic FDA data

ORPHENADRINE CITRATE

Product NDC
53002-5430
11-digit product format
530025430
Labeler code
53002
Product ID
53002-5430_ce37adfa-f4e3-4dfe-b9ca-212219aa4dff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA040284
Marketing category
ANDA
Marketing start
1998-06-19
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-5430-22025-01-30C16284748780-12cef2736-9063-d83d-e063-dadaa90ab31fOrphenadrine Citrate Extended-Release Tablets Rx Only
53002-5430-32025-01-30C16284748780-12cef2736-9063-d83d-e063-dadaa90ab31fOrphenadrine Citrate Extended-Release Tablets Rx Only
53002-5430-52025-01-30C16284748780-12cef2736-9063-d83d-e063-dadaa90ab31fOrphenadrine Citrate Extended-Release Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5430-2ORPHENADRINE CITRATE20 in 1 BOTTLETABLET, EXTENDED RELEASE201
53002-5430-3ORPHENADRINE CITRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE301
53002-5430-5ORPHENADRINE CITRATE15 in 1 BOTTLETABLET, EXTENDED RELEASE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5430ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20220331_b9595be2-0872-4d42-98d5-ba6f23a48774.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSNb9595be2-0872-4d42-98d5-ba6f23a487741
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCDb9595be2-0872-4d42-98d5-ba6f23a487741
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSYb9595be2-0872-4d42-98d5-ba6f23a487741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-5430-25300254300220 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-5430-2) 2022-07-010000-00-00NoNoCurrent
53002-5430-35300254300330 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-5430-3) 2022-07-010000-00-00NoNoCurrent
53002-5430-55300254300515 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-5430-5) 2022-07-010000-00-00NoNoCurrent