Orphenadrine Citrate

Product NDC
67296-1077
11-digit product format
672961077
Labeler code
67296
Product ID
67296-1077_1cff80d4-f7ae-a785-e063-6294a90ad77b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RedPharm Drug
Application
ANDA040327
Marketing category
ANDA
Marketing start
2000-02-15
Marketing end
2027-03-20
Substance
ORPHENADRINE CITRATE
Active strength
100 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orphenadrine Citrate

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
67296-1077-1Orphenadrine Citrate10 in 1 BOTTLETABLET, EXTENDED RELEASE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1077ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REDPHARM DRUG]1Current NDC, 1 package rows20240712_1cff761d-e594-a9e6-e063-6394a90a1fd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN1cff761d-e594-a9e6-e063-6394a90a1fd51
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD1cff761d-e594-a9e6-e063-6394a90a1fd51
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY1cff761d-e594-a9e6-e063-6394a90a1fd51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1077-16729610770110 TABLET, EXTENDED RELEASE in 1 BOTTLE (67296-1077-1) 2000-02-152027-03-20NoNoHistorical