Orphenadrine Citrate

Product NDC
25021-651
11-digit product format
250210651
Labeler code
25021
Product ID
25021-651_393d82d5-94f5-43fd-b5c8-d0554795233f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
orphenadrine citrate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090585
Marketing category
ANDA
Marketing start
2011-10-01
Substance
ORPHENADRINE CITRATE
Active strength
30 mg/mL
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 CITRATE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX0A40N8I4S
Rxcui994541

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-651-02Orphenadrine Citrate2 mL in 1 VIALINJECTION, SOLUTION25
25021-651-02Orphenadrine Citrate10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-651-02ML - Milliliter25021-651a553d72b-48fc-4e61-81b8-167d11edcdd312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-651ORPHENADRINE CITRATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20231227_c8d8596a-b81f-4b83-a2f3-a55922ca4a82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994541orphenadrine citrate 60 MG in 2 ML InjectionPSNc8d8596a-b81f-4b83-a2f3-a55922ca4a825
9945412 ML orphenadrine citrate 30 MG/ML InjectionSCDc8d8596a-b81f-4b83-a2f3-a55922ca4a825
994541orphenadrine citrate 60 MG per 2 ML InjectionSYc8d8596a-b81f-4b83-a2f3-a55922ca4a825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-651-022502106510210 VIAL in 1 CARTON (25021-651-02) / 2 mL in 1 VIAL10 vial2011-10-01NoNoCurrent