droxidopa

Generic: droxidopa

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name droxidopa
Generic Name droxidopa
Labeler bionpharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

droxidopa 300 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-258
Product ID 69452-258_c3cfd280-3549-b590-e053-2a95a90a5eb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213033
Listing Expiration 2026-12-31
Marketing Start 2021-10-01

Pharmacologic Class

Chemical Structure
catecholamines [cs]
Physiologic Effect
increased blood pressure [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452258
Hyphenated Format 69452-258

Supplemental Identifiers

RxCUI
1490026 1490034 1490038
UNII
J7A92W69L7
NUI
M0003647 N0000178478

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 droxidopa (source: ndc)
Generic Name droxidopa (source: ndc)
Application Number ANDA213033 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-258-19)
source: ndc

Packages (1)

69452-258-19 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-258-19)

Ingredients (1)

droxidopa (300 mg/1)

Linked Drug Pages (1)

DROXIDOPA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c3cfd280-3549-b590-e053-2a95a90a5eb3", "openfda": {"nui": ["M0003647", "N0000178478"], "unii": ["J7A92W69L7"], "rxcui": ["1490026", "1490034", "1490038"], "spl_set_id": ["c3cfd280-3548-b590-e053-2a95a90a5eb3"], "pharm_class_cs": ["Catecholamines [CS]"], "pharm_class_pe": ["Increased Blood Pressure [PE]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (69452-258-19)", "package_ndc": "69452-258-19", "marketing_start_date": "20211001"}], "brand_name": "DROXIDOPA", "product_id": "69452-258_c3cfd280-3549-b590-e053-2a95a90a5eb3", "dosage_form": "CAPSULE", "pharm_class": ["Catecholamines [CS]", "Increased Blood Pressure [PE]"], "product_ndc": "69452-258", "generic_name": "DROXIDOPA", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DROXIDOPA", "active_ingredients": [{"name": "DROXIDOPA", "strength": "300 mg/1"}], "application_number": "ANDA213033", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}