orphenadrine citrate

Generic: orphenadrine citrate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name orphenadrine citrate
Generic Name orphenadrine citrate
Labeler a-s medication solutions
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

orphenadrine citrate 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0169
Product ID 50090-0169_a11270c6-fe5e-4cfd-9a1e-f11abb0fe4a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040284
Listing Expiration 2027-12-31
Marketing Start 1998-06-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500900169
Hyphenated Format 50090-0169

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
  • 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-0)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-1)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-5)
source: ndc

Packages (3)

50090-0169-0 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-0) 50090-0169-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-1) 50090-0169-5 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-5)

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": "a11270c6-fe5e-4cfd-9a1e-f11abb0fe4a0", "openfda": {"unii": ["X0A40N8I4S"], "rxcui": ["994521"], "spl_set_id": ["80ef7fb4-7c50-4d25-915e-f9d4a2ccd199"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-0)", "package_ndc": "50090-0169-0", "marketing_start_date": "20160621"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-1)", "package_ndc": "50090-0169-1", "marketing_start_date": "20141128"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-5)", "package_ndc": "50090-0169-5", "marketing_start_date": "20141128"}], "brand_name": "Orphenadrine Citrate", "product_id": "50090-0169_a11270c6-fe5e-4cfd-9a1e-f11abb0fe4a0", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "50090-0169", "generic_name": "ORPHENADRINE CITRATE", "labeler_name": "A-S Medication Solutions", "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": "19980619", "listing_expiration_date": "20271231"}