salagen

Generic: pilocarpine hydrochloride

Labeler: advanz pharma (us) corp.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name salagen
Generic Name pilocarpine hydrochloride
Labeler advanz pharma (us) corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pilocarpine hydrochloride 5 mg/1

Manufacturer
Advanz Pharma (US) Corp.

Identifiers & Regulatory

Product NDC 59212-705
Product ID 59212-705_5e2a19b9-0694-43ac-9e0e-b40048495a1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020237
Listing Expiration 2026-12-31
Marketing Start 2019-09-01

Pharmacologic Class

Classes
cholinergic agonists [moa] cholinergic muscarinic agonists [moa] cholinergic receptor agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59212705
Hyphenated Format 59212-705

Supplemental Identifiers

RxCUI
1000913 1000915 1001004 1001006
UNII
0WW6D218XJ

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 salagen (source: ndc)
Generic Name pilocarpine hydrochloride (source: ndc)
Application Number NDA020237 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59212-705-10)
source: ndc

Packages (1)

59212-705-10 100 TABLET, FILM COATED in 1 BOTTLE (59212-705-10)

Ingredients (1)

pilocarpine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Salagen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5e2a19b9-0694-43ac-9e0e-b40048495a1b", "openfda": {"unii": ["0WW6D218XJ"], "rxcui": ["1000913", "1000915", "1001004", "1001006"], "spl_set_id": ["62eda83d-d043-4c7e-8fcf-75d05efbf35b"], "manufacturer_name": ["Advanz Pharma (US) Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59212-705-10)", "package_ndc": "59212-705-10", "marketing_start_date": "20190901"}], "brand_name": "Salagen", "product_id": "59212-705_5e2a19b9-0694-43ac-9e0e-b40048495a1b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "59212-705", "generic_name": "Pilocarpine Hydrochloride", "labeler_name": "Advanz Pharma (US) Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Salagen", "active_ingredients": [{"name": "PILOCARPINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA020237", "marketing_category": "NDA", "marketing_start_date": "20190901", "listing_expiration_date": "20261231"}