FDA.reportPublic FDA data

ORPHENADRINE CITRATE

Product NDC
43063-407
11-digit product format
430630407
Labeler code
43063
Product ID
43063-407_47d2a4d7-5572-e023-e063-6394a90a3617
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ORPHENADRINE CITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ORPHENADRINE CITRATE
Listing expiration
2027-12-31

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
43063-407-14ORPHENADRINE CITRATE14 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1435
43063-407-20ORPHENADRINE CITRATE20 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE2035
43063-407-30ORPHENADRINE CITRATE30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3035
43063-407-60ORPHENADRINE CITRATE60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-407-14EA - Each43063-407d6bbe865-d67e-4d9f-bad4-c483561269bd12020-05-08
43063-407-20EA - Each43063-4072bff7b74-b0cb-4c24-802e-55035f60648212014-05-02
43063-407-30EA - Each43063-407b3a879c2-7ca3-4d4f-9eab-acc8cf5fe3f112013-08-02
43063-407-60EA - Each43063-40749379e0a-a04c-45e2-af7b-36e62f4bff0112013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORPHENADRINE CITRATEACTIVE INGREDIENTX0A40N8I4SORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]16
ORPHENADRINEACTIVE MOIETYAL805O9OG9ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-407ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]32Current NDC, Legacy NDC, 4 package rows20240713_87d78229-f022-4b42-a03c-4e6a985c714f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994521orphenadrine citrate 100 MG 12HR Extended Release Oral TabletPSN87d78229-f022-4b42-a03c-4e6a985c714f35
99452112 HR orphenadrine citrate 100 MG Extended Release Oral TabletSCD87d78229-f022-4b42-a03c-4e6a985c714f35
994521orphenadrine citrate 100 MG 12 HR Extended Release Oral TabletSY87d78229-f022-4b42-a03c-4e6a985c714f35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-407-144306304071414 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-14) 2013-06-180000-00-00NoNoCurrent
43063-407-204306304072020 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-20) 2013-06-180000-00-00NoNoCurrent
43063-407-304306304073030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-30) 2013-06-180000-00-00NoNoCurrent
43063-407-604306304076060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-60) 2013-06-180000-00-00NoNoCurrent