Orphenadrine Citrate

Product NDC
50090-0169
11-digit product format
500900169
Labeler code
50090
Product ID
50090-0169_a11270c6-fe5e-4cfd-9a1e-f11abb0fe4a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040284
Marketing category
ANDA
Marketing start
1998-06-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orphenadrine Citrate
Listing expiration
2027-12-31

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
50090-0169-0Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE2019
50090-0169-1Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE3019
50090-0169-2Orphenadrine Citrate14 in 1 BOTTLETABLET, EXTENDED RELEASE1419
50090-0169-5Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0169-0EA - Each50090-01698d113a9c-ac81-480d-8b7d-2c1cbc2a9a3e12018-08-13
50090-0169-1EA - Each50090-016905646391-f849-481e-941d-bf62a5bb1a8d12018-08-13
50090-0169-2EA - Each50090-016929b136af-8ccb-42cb-9790-ba341f92f4ab12018-08-13
50090-0169-5EA - Each50090-0169a83b1cdd-583f-4fd5-8337-0d90a87e252f12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0169ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 4 package rows20231204_80ef7fb4-7c50-4d25-915e-f9d4a2ccd199.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN80ef7fb4-7c50-4d25-915e-f9d4a2ccd19919
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD80ef7fb4-7c50-4d25-915e-f9d4a2ccd19919
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY80ef7fb4-7c50-4d25-915e-f9d4a2ccd19919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0169-05009001690020 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-0) 2016-06-210000-00-00NoNoCurrent
50090-0169-15009001690130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-1) 2014-11-280000-00-00NoNoCurrent
50090-0169-25009001690214 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-2) 2014-11-280000-00-00NoNoCurrent
50090-0169-55009001690560 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-5) 2014-11-280000-00-00NoNoCurrent