Orphenadrine Citrate

Product NDC
61919-177
11-digit product format
619190177
Labeler code
61919
Product ID
61919-177_e545faea-ca89-2434-e053-2995a90a7d59
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
2019-08-29
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
61919-177-202020-01-31C16284748780-19d75b9cf-d01f-f424-e053-dadaa90a57ceOrphenadrine Citrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-177-72Orphenadrine Citrate120 in 1 BOTTLETABLET, EXTENDED RELEASE1205
61919-177-20Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE203
61919-177-30Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE303
61919-177-60Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE603
61919-177-90Orphenadrine Citrate90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-177-20EA - Each61919-17797e7afef-3848-40cf-af74-f6838417b40c12016-02-04
61919-177-30EA - Each61919-177f362821d-227f-4531-a6af-a8e990f8f42512014-05-02
61919-177-60EA - Each61919-17707f61c76-9f1b-48f7-9e71-b8affbde9aaa12014-05-02
61919-177-72EA - Each61919-177ad5555c0-49ae-4b1a-adba-f8c96807ec7512019-09-05
61919-177-90EA - Each61919-1775b5719f7-999c-46c2-9f06-8b89f9026f5612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORPHENADRINE CITRATEACTIVE INGREDIENTX0A40N8I4SORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]2
ORPHENADRINEACTIVE MOIETYAL805O9OG9ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-177ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT_RX]5Legacy NDC, 1 package rows20240110_91436f1e-8b05-435c-e053-2a95a90ae21f.zip
61919-177ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [DIRECT RX]3Legacy NDC, 4 package rows20151212_8a258480-2f47-4b62-850c-1beed383ba29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN91436f1e-8b05-435c-e053-2a95a90ae21f5
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD91436f1e-8b05-435c-e053-2a95a90ae21f5
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY91436f1e-8b05-435c-e053-2a95a90ae21f5
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN8a258480-2f47-4b62-850c-1beed383ba293
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD8a258480-2f47-4b62-850c-1beed383ba293
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY8a258480-2f47-4b62-850c-1beed383ba293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-177-206191901772020 in 1 BOTTLEHistorical
61919-177-306191901773030 in 1 BOTTLEHistorical
61919-177-606191901776060 in 1 BOTTLEHistorical
61919-177-7261919017772120 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-177-72) 2019-08-290000-00-00NoNoCurrent
61919-177-906191901779090 in 1 BOTTLEHistorical