droxidopa

Generic: droxidopa

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

Drug Facts

Product Profile

Brand Name droxidopa
Generic Name droxidopa
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

droxidopa 200 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-988
Product ID 68180-988_0098094d-a0c0-4b55-9851-68aaf0109233
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211652
Listing Expiration 2026-12-31
Marketing Start 2021-09-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180988
Hyphenated Format 68180-988

Supplemental Identifiers

RxCUI
1490026 1490034 1490038
UPC
0368180989097
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 ANDA211652 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Droxidopa capsules are supplied in the following dosage strengths: 100 mg: Hard gelatin, size 3 capsule, with an opaque light blue cap and an opaque white body, printed with "D26" on cap and "LU" on body using black ink and filled with a white to light brown granular powder. 200 mg: Hard gelatin, size 2 capsule, with an opaque light yellow cap and an opaque white body, printed with "D27" on cap and "LU" on body using black ink and filled with a white to light brown granular powder. 300 mg: Hard gelatin, size 1 capsule, with an opaque light green cap and an opaque white body, printed with "D28" on cap and "LU" on body using black ink and filled with a white to light brown granular powder. 100 mg 90-count bottle (NDC code# 68180-987-09) 500-count bottle (NDC code# 68180-987-02) 200 mg 90-count bottle (NDC code# 68180-988-09) 500-count bottle (NDC code# 68180-988-02) 300 mg 90-count bottle (NDC code# 68180-989-09) 500-count bottle (NDC code# 68180-989-02) 16.2 Storage and Handling Droxidopa capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Dispense in a tight, light-resistant container with a child resistant closure
  • 16.1 How Supplied Droxidopa capsules are supplied in the following dosage strengths: 100 mg: Hard gelatin, size 3 capsule, with an opaque light blue cap and an opaque white body, printed with "D26" on cap and "LU" on body using black ink and filled with a white to light brown granular powder. 200 mg: Hard gelatin, size 2 capsule, with an opaque light yellow cap and an opaque white body, printed with "D27" on cap and "LU" on body using black ink and filled with a white to light brown granular powder. 300 mg: Hard gelatin, size 1 capsule, with an opaque light green cap and an opaque white body, printed with "D28" on cap and "LU" on body using black ink and filled with a white to light brown granular powder. 100 mg 90-count bottle (NDC code# 68180-987-09) 500-count bottle (NDC code# 68180-987-02) 200 mg 90-count bottle (NDC code# 68180-988-09) 500-count bottle (NDC code# 68180-988-02) 300 mg 90-count bottle (NDC code# 68180-989-09) 500-count bottle (NDC code# 68180-989-02)
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68180-987-09 Droxidopa Capsules 100 mg Bottle of 90's Capsules NDC 68180-988-09 Droxidopa Capsules 200 mg Bottle of 90's Capsules NDC 68180-989-09 Droxidopa Capsules 300 mg Bottle of 90's Capsules Image Image Image
source: label

Packages (0)

No package records.

Ingredients (1)

droxidopa (200 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": "0098094d-a0c0-4b55-9851-68aaf0109233", "openfda": {"nui": ["M0003647", "N0000178478"], "upc": ["0368180989097"], "unii": ["J7A92W69L7"], "rxcui": ["1490026", "1490034", "1490038"], "spl_set_id": ["81b798dc-b8dc-48a5-af46-82bb55f789a8"], "pharm_class_cs": ["Catecholamines [CS]"], "pharm_class_pe": ["Increased Blood Pressure [PE]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "DROXIDOPA", "product_id": "68180-988_0098094d-a0c0-4b55-9851-68aaf0109233", "dosage_form": "CAPSULE", "pharm_class": ["Catecholamines [CS]", "Increased Blood Pressure [PE]"], "product_ndc": "68180-988", "generic_name": "DROXIDOPA", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DROXIDOPA", "active_ingredients": [{"name": "DROXIDOPA", "strength": "200 mg/1"}], "application_number": "ANDA211652", "marketing_category": "ANDA", "marketing_start_date": "20210924", "listing_expiration_date": "20261231"}