ORPHENADRINE CITRATE

Product NDC
61919-507
11-digit product format
619190507
Labeler code
61919
Product ID
61919-507_9cab5838-6e00-a78d-e053-2995a90a095e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040284
Marketing category
ANDA
Marketing start
2018-03-26
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-507-302023-01-30C16284748780-1f386c64a-1b5d-0266-e053-dadaa90a7c1aORPHENADRINE CITRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-507-30ORPHENADRINE CITRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-507-30EA - Each61919-5071867435a-03ef-4024-a9e2-5d7fc6114ef412018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-507ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]2Legacy NDC, 1 package rows20200122_68520968-23bb-6ae9-e053-2991aa0a773d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN68520968-23bb-6ae9-e053-2991aa0a773d2
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD68520968-23bb-6ae9-e053-2991aa0a773d2
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY68520968-23bb-6ae9-e053-2991aa0a773d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-507-306191905073030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-507-30) 2018-03-260000-00-00NoNoCurrent