orphenadrine citrate

Generic: orphenadrine citrate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

orphenadrine citrate 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-407
Product ID 43063-407_47d2a4d7-5572-e023-e063-6394a90a3617
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 43063407
Hyphenated Format 43063-407

Supplemental Identifiers

RxCUI
994521
UPC
0343063407301
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 (43063-407-14)
  • 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-20)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-60)
source: ndc

Packages (4)

43063-407-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-14) 43063-407-20 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-20) 43063-407-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-30) 43063-407-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-60)

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": "47d2a4d7-5572-e023-e063-6394a90a3617", "openfda": {"upc": ["0343063407301"], "unii": ["X0A40N8I4S"], "rxcui": ["994521"], "spl_set_id": ["87d78229-f022-4b42-a03c-4e6a985c714f"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-14)", "package_ndc": "43063-407-14", "marketing_start_date": "20130618"}, {"sample": false, "description": "20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-20)", "package_ndc": "43063-407-20", "marketing_start_date": "20130618"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-30)", "package_ndc": "43063-407-30", "marketing_start_date": "20130618"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-60)", "package_ndc": "43063-407-60", "marketing_start_date": "20130618"}], "brand_name": "ORPHENADRINE CITRATE", "product_id": "43063-407_47d2a4d7-5572-e023-e063-6394a90a3617", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "43063-407", "generic_name": "ORPHENADRINE CITRATE", "labeler_name": "PD-Rx 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": "20271231"}