orphenadrine citrate

Generic: orphenadrine citrate

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name orphenadrine citrate
Generic Name orphenadrine citrate
Labeler northwind health company, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

orphenadrine citrate 100 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-040
Product ID 82868-040_47f8f308-ca39-d280-e063-6394a90a49e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040284
Listing Expiration 2027-12-31
Marketing Start 2024-01-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868040
Hyphenated Format 82868-040

Supplemental Identifiers

RxCUI
994521
UNII
X0A40N8I4S

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 ANDA040284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-040-14)
source: ndc

Packages (1)

82868-040-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-040-14)

Ingredients (1)

orphenadrine citrate (100 mg/1)

Linked Drug Pages (1)

ORPHENADRINE CITRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47f8f308-ca39-d280-e063-6394a90a49e9", "openfda": {"unii": ["X0A40N8I4S"], "rxcui": ["994521"], "spl_set_id": ["106be130-b4f8-5ca1-e063-6294a90a1590"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-040-14)", "package_ndc": "82868-040-14", "marketing_start_date": "20240130"}], "brand_name": "ORPHENADRINE CITRATE", "product_id": "82868-040_47f8f308-ca39-d280-e063-6394a90a49e9", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "82868-040", "generic_name": "ORPHENADRINE CITRATE", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ORPHENADRINE CITRATE", "active_ingredients": [{"name": "ORPHENADRINE CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA040284", "marketing_category": "ANDA", "marketing_start_date": "20240130", "listing_expiration_date": "20271231"}