FDA.reportPublic FDA data

Orphenadrine Citrate

Product NDC
63187-632
11-digit product format
631870632
Labeler code
63187
Product ID
63187-632_77186922-128f-4ed4-8caa-b45fce773345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040327
Marketing category
ANDA
Marketing start
2000-02-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orphenadrine Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ORPHENADRINE CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0A40N8I4S
Rxcui994521

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-632-30Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE302
63187-632-60Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE602
63187-632-90Orphenadrine Citrate90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-632-60EA - Each63187-632718ebdd6-ad7b-430f-bc1e-c11b74fb13fd12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-632ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191128_37e6a157-5d0d-4887-9a26-ed5521fb08e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN37e6a157-5d0d-4887-9a26-ed5521fb08e62
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD37e6a157-5d0d-4887-9a26-ed5521fb08e62
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY37e6a157-5d0d-4887-9a26-ed5521fb08e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-632-306318706323030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-30) 2016-01-010000-00-00NoNoCurrent
63187-632-606318706326060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-60) 2016-01-010000-00-00NoNoCurrent
63187-632-906318706329090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-632-90) 2016-01-010000-00-00NoNoCurrent