Orphenadrine Citrate

Product NDC
63187-122
11-digit product format
631870122
Labeler code
63187
Product ID
63187-122_6733ab80-4fe3-4bdb-8e81-3beb50b5db0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Orphenadrine Citrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-122-20Orphenadrine Citrate20 in 1 BOTTLETABLET, EXTENDED RELEASE206
63187-122-30Orphenadrine Citrate30 in 1 BOTTLETABLET, EXTENDED RELEASE306
63187-122-60Orphenadrine Citrate60 in 1 BOTTLETABLET, EXTENDED RELEASE606
63187-122-90Orphenadrine Citrate90 in 1 BOTTLETABLET, EXTENDED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-122-30EA - Each63187-1223d231946-c144-46d1-8044-9fd5c541c40712018-08-13
63187-122-60EA - Each63187-12235f0c27c-229f-493d-8a15-8f9e2d93c4ae12015-07-20

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-122ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20231207_cf620257-7497-44c1-9853-87f96d262fbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSNcf620257-7497-44c1-9853-87f96d262fbd6
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCDcf620257-7497-44c1-9853-87f96d262fbd6
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSYcf620257-7497-44c1-9853-87f96d262fbd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-122-206318701222020 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-20) 2015-02-020000-00-00NoNoCurrent
63187-122-306318701223030 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-30) 2015-02-020000-00-00NoNoCurrent
63187-122-606318701226060 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-60) 2015-02-020000-00-00NoNoCurrent
63187-122-906318701229090 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-90) 2015-02-020000-00-00NoNoCurrent