orphenadrine citrate er

Generic: orphenadrine citrate

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name orphenadrine citrate er
Generic Name orphenadrine citrate
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

orphenadrine citrate 100 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0117
Product ID 80425-0117_2a996b2b-b5dc-65e7-e063-6394a90adeed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040284
Listing Expiration 2026-12-31
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 804250117
Hyphenated Format 80425-0117

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 er (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
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-1)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-2)
source: ndc

Packages (2)

80425-0117-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-1) 80425-0117-2 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-2)

Ingredients (1)

orphenadrine citrate (100 mg/1)

Linked Drug Pages (1)

Orphenadrine Citrate ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a996b2b-b5dc-65e7-e063-6394a90adeed", "openfda": {"unii": ["X0A40N8I4S"], "rxcui": ["994521"], "spl_set_id": ["b5a6846a-ebb3-1fdd-e053-2a95a90a4130"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-1)", "package_ndc": "80425-0117-1", "marketing_start_date": "19980619"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-2)", "package_ndc": "80425-0117-2", "marketing_start_date": "20230817"}], "brand_name": "Orphenadrine Citrate ER", "product_id": "80425-0117_2a996b2b-b5dc-65e7-e063-6394a90adeed", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "80425-0117", "generic_name": "Orphenadrine Citrate", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orphenadrine Citrate", "brand_name_suffix": "ER", "active_ingredients": [{"name": "ORPHENADRINE CITRATE", "strength": "100 mg/1"}], "application_number": "ANDA040284", "marketing_category": "ANDA", "marketing_start_date": "19980619", "listing_expiration_date": "20261231"}