orphenadrine citrate

Generic: orphenadrine citrate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name orphenadrine citrate
Generic Name orphenadrine citrate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

orphenadrine citrate 60 mg/2mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6182
Product ID 0641-6182_dde13b7f-78fb-4b9a-bc16-a41bf45042be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040463
Listing Expiration 2026-12-31
Marketing Start 2003-04-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416182
Hyphenated Format 0641-6182

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 ANDA040463 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/2mL
source: ndc
Packaging
  • 25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01)
source: ndc

Packages (1)

0641-6182-25 25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01)

Ingredients (1)

orphenadrine citrate (60 mg/2mL)

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": "dde13b7f-78fb-4b9a-bc16-a41bf45042be", "openfda": {"unii": ["X0A40N8I4S"], "rxcui": ["994541"], "spl_set_id": ["ed406e8a-ec00-4711-ae2b-3c5af4f15438"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 BOX in 1 BOX (0641-6182-25)  / 10 VIAL in 1 BOX (0641-6182-10)  / 2 mL in 1 VIAL (0641-6182-01)", "package_ndc": "0641-6182-25", "marketing_start_date": "20030428"}], "brand_name": "Orphenadrine citrate", "product_id": "0641-6182_dde13b7f-78fb-4b9a-bc16-a41bf45042be", "dosage_form": "INJECTION", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0641-6182", "generic_name": "Orphenadrine citrate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orphenadrine citrate", "active_ingredients": [{"name": "ORPHENADRINE CITRATE", "strength": "60 mg/2mL"}], "application_number": "ANDA040463", "marketing_category": "ANDA", "marketing_start_date": "20030428", "listing_expiration_date": "20261231"}