apraclonidine

Generic: apraclonidine

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name apraclonidine
Generic Name apraclonidine
Labeler sandoz inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

apraclonidine hydrochloride 5.75 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-665
Product ID 61314-665_238af96f-2f89-9af4-e063-6394a90a9516
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020258
Listing Expiration 2026-12-31
Marketing Start 2009-07-19

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314665
Hyphenated Format 61314-665

Supplemental Identifiers

RxCUI
308345
UPC
0361314665058 0361314665102
UNII
D2VW67N38H

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 apraclonidine (source: ndc)
Generic Name apraclonidine (source: ndc)
Application Number NDA020258 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5.75 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (61314-665-05)
  • 10 mL in 1 BOTTLE (61314-665-10)
source: ndc

Packages (2)

61314-665-05 5 mL in 1 BOTTLE (61314-665-05) 61314-665-10 10 mL in 1 BOTTLE (61314-665-10)

Ingredients (1)

apraclonidine hydrochloride (5.75 mg/mL)

Linked Drug Pages (1)

Apraclonidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "238af96f-2f89-9af4-e063-6394a90a9516", "openfda": {"upc": ["0361314665058", "0361314665102"], "unii": ["D2VW67N38H"], "rxcui": ["308345"], "spl_set_id": ["04ad82af-e7ba-4f40-a120-be9d33cf0c7b"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (61314-665-05)", "package_ndc": "61314-665-05", "marketing_start_date": "20090719"}, {"sample": false, "description": "10 mL in 1 BOTTLE (61314-665-10)", "package_ndc": "61314-665-10", "marketing_start_date": "20090719"}], "brand_name": "Apraclonidine", "product_id": "61314-665_238af96f-2f89-9af4-e063-6394a90a9516", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "61314-665", "generic_name": "Apraclonidine", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Apraclonidine", "active_ingredients": [{"name": "APRACLONIDINE HYDROCHLORIDE", "strength": "5.75 mg/mL"}], "application_number": "NDA020258", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20090719", "listing_expiration_date": "20261231"}