onapgo

Generic: apomorphine hydrochloride

Labeler: mdd us operations, llc, a subsidiary of supernus pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name onapgo
Generic Name apomorphine hydrochloride
Labeler mdd us operations, llc, a subsidiary of supernus pharmaceuticals, inc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

apomorphine hydrochloride 4.9 mg/mL

Manufacturer
MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 27505-006
Product ID 27505-006_4aa2a34c-370f-9da6-e063-6394a90ac79b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214056
Listing Expiration 2027-12-31
Marketing Start 2025-02-04

Pharmacologic Class

Classes
dopamine agonists [moa] dopaminergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27505006
Hyphenated Format 27505-006

Supplemental Identifiers

RxCUI
2705789 2705796
UNII
F39049Y068

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 onapgo (source: ndc)
Generic Name apomorphine hydrochloride (source: ndc)
Application Number NDA214056 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 4.9 mg/mL
source: ndc
Packaging
  • 5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01)
source: ndc

Packages (1)

27505-006-05 5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01)

Ingredients (1)

apomorphine hydrochloride (4.9 mg/mL)

Linked Drug Pages (1)

ONAPGO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "4aa2a34c-370f-9da6-e063-6394a90ac79b", "openfda": {"unii": ["F39049Y068"], "rxcui": ["2705789", "2705796"], "spl_set_id": ["f3552b6e-5ae7-4993-aa1a-e399c4a7080a"], "manufacturer_name": ["MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 CARTRIDGE in 1 CARTON (27505-006-05)  / 20 mL in 1 CARTRIDGE (27505-006-01)", "package_ndc": "27505-006-05", "marketing_start_date": "20250204"}], "brand_name": "ONAPGO", "product_id": "27505-006_4aa2a34c-370f-9da6-e063-6394a90ac79b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Dopamine Agonists [MoA]", "Dopaminergic Agonist [EPC]"], "product_ndc": "27505-006", "generic_name": "Apomorphine hydrochloride", "labeler_name": "MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONAPGO", "active_ingredients": [{"name": "APOMORPHINE HYDROCHLORIDE", "strength": "4.9 mg/mL"}], "application_number": "NDA214056", "marketing_category": "NDA", "marketing_start_date": "20250204", "listing_expiration_date": "20271231"}