orphenadrine citrate

Generic: orphenadrine citrate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name orphenadrine citrate
Generic Name orphenadrine citrate
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

orphenadrine citrate 100 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43386-480
Product ID 43386-480_e80ecc89-bd45-4796-850b-c379a79ac7ab
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 43386480
Hyphenated Format 43386-480

Supplemental Identifiers

RxCUI
994521
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 ANDA040284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-28)
source: ndc

Packages (3)

43386-480-24 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24) 43386-480-26 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26) 43386-480-28 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-28)

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": "e80ecc89-bd45-4796-850b-c379a79ac7ab", "openfda": {"unii": ["X0A40N8I4S"], "rxcui": ["994521"], "spl_set_id": ["7b76c8a7-dd0c-481c-8299-26dfd38ce066"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24)", "package_ndc": "43386-480-24", "marketing_start_date": "19980619"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26)", "package_ndc": "43386-480-26", "marketing_start_date": "19980619"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-28)", "package_ndc": "43386-480-28", "marketing_start_date": "19980619"}], "brand_name": "ORPHENADRINE CITRATE", "product_id": "43386-480_e80ecc89-bd45-4796-850b-c379a79ac7ab", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "43386-480", "generic_name": "ORPHENADRINE CITRATE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "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": "20261231"}