ORPHENADRINE CITRATE

Product NDC
72162-2020
11-digit product format
721622020
Labeler code
72162
Product ID
72162-2020_4bc4698c-3d3c-e862-e063-6394a90a142f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
72162-2020-1ORPHENADRINE CITRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE100103
72162-2020-5ORPHENADRINE CITRATE500 in 1 BOTTLETABLET, EXTENDED RELEASE500103
72162-2020-6ORPHENADRINE CITRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2020-1EA - Each72162-202050325107-f7ed-4ec7-9fda-e69b86e203b612023-07-06
72162-2020-5EA - Each72162-202084a1331d-6cb4-4db2-a694-61328e6c1cd512023-07-06
72162-2020-6EA - Each72162-20204bfd1aa2-286e-4cf4-b919-69d4df25659912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2020ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 3 package rows20240331_1b4e379e-8051-421f-a0f4-ad9e6fb9476a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN1b4e379e-8051-421f-a0f4-ad9e6fb9476a103
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD1b4e379e-8051-421f-a0f4-ad9e6fb9476a103
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY1b4e379e-8051-421f-a0f4-ad9e6fb9476a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2020-172162202001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2020-1) 2023-05-26NoNoHistorical
72162-2020-572162202005500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2020-5) 2023-05-26NoNoHistorical
72162-2020-67216220200660 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2020-6) 2023-05-26NoNoHistorical