FDA.reportPublic FDA data

Orphenadrine Citrate

Product NDC
63629-1564
11-digit product format
636291564
Labeler code
63629
Product ID
63629-1564_1a6afbdf-cba9-4ed0-9d82-1f47fb32dd7a
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1564-02020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-12020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-22020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-32020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-42020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-52020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-62020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-72020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-82020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-92020-10-13C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-02020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-12020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-22020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-32020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-42020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-52020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-62020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-72020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-82020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only
63629-1564-92020-01-31C16284748780-19d75b9d0-4330-f424-e053-dadaa90a57ceOrphenadrine Citrate Extended-Release Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1564-0Orphenadrine Citrate56 in 1 BOTTLETABLET, EXTENDED RELEASE5619
63629-1564-1Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE2019
63629-1564-2Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE6019
63629-1564-3Orphenadrine Citrate100 in 1 BOTTLETABLET, EXTENDED RELEASE10019
63629-1564-4Orphenadrine Citrate90 in 1 BOTTLETABLET, EXTENDED RELEASE9019
63629-1564-5Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE3019
63629-1564-6Orphenadrine Citrate28 in 1 BOTTLETABLET, EXTENDED RELEASE2819
63629-1564-7Orphenadrine Citrate45 in 1 BOTTLETABLET, EXTENDED RELEASE4519
63629-1564-8Orphenadrine Citrate14 in 1 BOTTLETABLET, EXTENDED RELEASE1419
63629-1564-9Orphenadrine Citrate120 in 1 BOTTLETABLET, EXTENDED RELEASE12019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1564-1EA - Each63629-1564368749c3-ec9a-4b58-aaba-77979e91db4912012-07-24
63629-1564-2EA - Each63629-1564fa6318ab-80ec-4a33-82b4-2261379b4ae712012-07-24
63629-1564-3EA - Each63629-15645ab3c22b-89aa-4a8a-85cb-535afcadaf2b12015-02-02
63629-1564-4EA - Each63629-1564043817cb-d043-4733-9992-80c0d613f6f112015-02-02
63629-1564-5EA - Each63629-1564004f21d9-27d5-4a22-9aab-6c263951035d12015-02-02
63629-1564-6EA - Each63629-15642ce06f16-66ca-489d-a947-ccbdf20c726d12015-02-02
63629-1564-7EA - Each63629-15643d78d3bf-358a-4508-b13c-3774a731eeba12015-02-02
63629-1564-8EA - Each63629-156487d21394-af31-4cb9-ba3d-242a9461d37812015-02-02
63629-1564-9EA - Each63629-15645cf24f4e-b535-4928-9204-f8b519b9cae312015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORPHENADRINE CITRATEACTIVE INGREDIENTX0A40N8I4SORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
ORPHENADRINEACTIVE MOIETYAL805O9OG9ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1564ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]19Current NDC, Legacy NDC, 10 package rows20240829_8408d24e-3948-548d-bb12-b1edf0c05e12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN8408d24e-3948-548d-bb12-b1edf0c05e1219
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD8408d24e-3948-548d-bb12-b1edf0c05e1219
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY8408d24e-3948-548d-bb12-b1edf0c05e1219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1564-06362915640056 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-0) 2006-09-220000-00-00NoNoCurrent
63629-1564-16362915640120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-1) 2006-09-220000-00-00NoNoCurrent
63629-1564-26362915640260 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-2) 2006-09-220000-00-00NoNoCurrent
63629-1564-363629156403100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-3) 2006-09-220000-00-00NoNoCurrent
63629-1564-46362915640490 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-4) 2006-09-220000-00-00NoNoCurrent
63629-1564-56362915640530 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-5) 2006-09-220000-00-00NoNoCurrent
63629-1564-66362915640628 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-6) 2006-09-220000-00-00NoNoCurrent
63629-1564-76362915640745 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-7) 2006-09-220000-00-00NoNoCurrent
63629-1564-86362915640814 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-8) 2006-09-220000-00-00NoNoCurrent
63629-1564-963629156409120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-9) 2006-09-220000-00-00NoNoCurrent