FDA.reportPublic FDA data

ORPHENADRINE CITRATE

Product NDC
80425-0340
11-digit product format
804250340
Labeler code
80425
Product ID
80425-0340_2a9ba8f4-6cf3-e827-e063-6394a90a0300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA040284
Marketing category
ANDA
Marketing start
2023-05-23
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
80425-0340-1ORPHENADRINE CITRATE30 in 1 BOTTLETABLET, EXTENDED RELEASE303
80425-0340-2ORPHENADRINE CITRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0340-1EA - Each80425-03405d392b19-64f9-4fac-ae6b-8682fc50bd9112023-07-06
80425-0340-2EA - Each80425-0340c5510cef-7513-4a88-8e89-ff89c258f3c912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0340ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 2 package rows20250102_fc63d413-39bd-409d-e053-6294a90a1463.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSNfc63d413-39bd-409d-e053-6294a90a14633
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCDfc63d413-39bd-409d-e053-6294a90a14633
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSYfc63d413-39bd-409d-e053-6294a90a14633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0340-18042503400130 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0340-1) 2023-05-23NoNoCurrent
80425-0340-28042503400260 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0340-2) 2023-08-17NoNoCurrent