orphenadrine citrate

Generic: orphenadrine citrate

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name orphenadrine citrate
Generic Name orphenadrine citrate
Labeler actavis pharma, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

orphenadrine citrate 30 mg/mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3222
Product ID 0591-3222_76bd2057-e1ac-4529-9663-f6139218eeab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084779
Listing Expiration 2026-12-31
Marketing Start 2010-07-08

Pharmacologic Class

Classes
centrally-mediated muscle relaxation [pe] muscle relaxant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05913222
Hyphenated Format 0591-3222

Supplemental Identifiers

RxCUI
994541
UNII
X0A40N8I4S

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name orphenadrine citrate (source: ndc)
Generic Name orphenadrine citrate (source: ndc)
Application Number ANDA084779 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (0591-3222-47) / 2 mL in 1 AMPULE (0591-3222-02)
source: ndc

Packages (1)

0591-3222-47 10 AMPULE in 1 CARTON (0591-3222-47) / 2 mL in 1 AMPULE (0591-3222-02)

Ingredients (1)

orphenadrine citrate (30 mg/mL)

Linked Drug Pages (1)

Orphenadrine Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "76bd2057-e1ac-4529-9663-f6139218eeab", "openfda": {"unii": ["X0A40N8I4S"], "rxcui": ["994541"], "spl_set_id": ["aec8ad3a-f717-4e74-b7b9-19debdaad79a"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (0591-3222-47)  / 2 mL in 1 AMPULE (0591-3222-02)", "package_ndc": "0591-3222-47", "marketing_start_date": "20100708"}], "brand_name": "Orphenadrine Citrate", "product_id": "0591-3222_76bd2057-e1ac-4529-9663-f6139218eeab", "dosage_form": "INJECTION", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0591-3222", "generic_name": "Orphenadrine Citrate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orphenadrine Citrate", "active_ingredients": [{"name": "ORPHENADRINE CITRATE", "strength": "30 mg/mL"}], "application_number": "ANDA084779", "marketing_category": "ANDA", "marketing_start_date": "20100708", "listing_expiration_date": "20261231"}