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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
X0A40N8I4SORPHENADRINE CITRATE4682-36-4ORPHENADRINE CITRATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0340-18042503400130 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0340-1) 2023-05-23NoNoHistorical
80425-0340-28042503400260 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0340-2) 2023-08-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Orphenadrine Citrate Extended-Release Tablets Rx OnlyAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL3