Orphenadrine Citrate

Product NDC
69784-905
11-digit product format
697840905
Labeler code
69784
Product ID
69784-905_60b2e28d-8356-60dd-e053-2a91aa0a3c5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Woodward Pharma Services LLC
Application
ANDA040249
Marketing category
ANDA
Marketing start
2017-05-26
Marketing end
0000-00-00
Substance
ORPHENADRINE CITRATE
Active strength
100 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69784-905-012025-09-17C16284748780-19d75b9d0-9a75-f424-e053-dadaa90a57ce5b317bfd-633d-0ce1-e053-2991aa0aa4c3
69784-905-012020-01-31C16284748780-19d75b9d0-9a75-f424-e053-dadaa90a57ce5b317bfd-633d-0ce1-e053-2991aa0aa4c3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-905ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [WOODWARD PHARMA SERVICES LLC]3Legacy NDC20171219_5b317bfd-633d-0ce1-e053-2991aa0aa4c3.zip