droxidopa

Generic: droxidopa

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name droxidopa
Generic Name droxidopa
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

droxidopa 300 ug/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-112
Product ID 63304-112_ca97f06d-5449-4f4f-a362-47f65448bf8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214384
Listing Expiration 2026-12-31
Marketing Start 2021-02-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304112
Hyphenated Format 63304-112

Supplemental Identifiers

UPC
0363304104905 0363304086904
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 ANDA214384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 ug/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (63304-112-90)
source: ndc

Packages (1)

63304-112-90 90 CAPSULE in 1 BOTTLE (63304-112-90)

Ingredients (1)

droxidopa (300 ug/1)

Linked Drug Pages (1)

droxidopa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ca97f06d-5449-4f4f-a362-47f65448bf8c", "openfda": {"nui": ["M0003647", "N0000178478"], "upc": ["0363304104905", "0363304086904"], "unii": ["J7A92W69L7"], "spl_set_id": ["51ef3096-4622-4f45-a180-ab0dc6d46df9"], "pharm_class_cs": ["Catecholamines [CS]"], "pharm_class_pe": ["Increased Blood Pressure [PE]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (63304-112-90)", "package_ndc": "63304-112-90", "marketing_start_date": "20210218"}], "brand_name": "droxidopa", "product_id": "63304-112_ca97f06d-5449-4f4f-a362-47f65448bf8c", "dosage_form": "CAPSULE", "pharm_class": ["Catecholamines [CS]", "Increased Blood Pressure [PE]"], "product_ndc": "63304-112", "generic_name": "droxidopa", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "droxidopa", "active_ingredients": [{"name": "DROXIDOPA", "strength": "300 ug/1"}], "application_number": "ANDA214384", "marketing_category": "ANDA", "marketing_start_date": "20210218", "listing_expiration_date": "20261231"}