FDA.reportPublic FDA data

Orphenadrine Citrate

Product NDC
0185-0022
11-digit product format
001850022
Labeler code
0185
Product ID
0185-0022_de0e8cdb-788a-4ebe-969d-14d44a14ddc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
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
0185-0022-01Orphenadrine Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE10021
0185-0022-10Orphenadrine Citrate1000 in 1 BOTTLETABLET, EXTENDED RELEASE100021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0022ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [SANDOZ INC]21Current NDC, Legacy NDC, 2 package rows20240322_239018ff-cec6-46de-ae9d-26c9ec034a32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN239018ff-cec6-46de-ae9d-26c9ec034a3221
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD239018ff-cec6-46de-ae9d-26c9ec034a3221
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY239018ff-cec6-46de-ae9d-26c9ec034a3221
994841orphenadrine citrate 100 MG Oral TabletPSN9c986cc2-3b57-43c4-b6c8-55ea6383ec9d4
994841orphenadrine citrate 100 MG Oral TabletSCD9c986cc2-3b57-43c4-b6c8-55ea6383ec9d4
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
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN1cff761d-e594-a9e6-e063-6394a90a1fd51
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN1d38a57b-946f-0776-e054-00144ff8d46c1
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD1cff761d-e594-a9e6-e063-6394a90a1fd51
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD1d38a57b-946f-0776-e054-00144ff8d46c1
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY1cff761d-e594-a9e6-e063-6394a90a1fd51
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY1d38a57b-946f-0776-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-0022-0100185002201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-01) 2000-02-152027-03-20NoNoCurrent
0185-0022-10001850022101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-10) 2000-02-150000-00-00NoNoCurrent