pilocarpine hydrochloride

Generic: pilocarpine hydrochloride

Labeler: amici pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pilocarpine hydrochloride
Generic Name pilocarpine hydrochloride
Labeler amici pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

pilocarpine hydrochloride 5 mg/1

Manufacturer
AMICI PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 69292-265
Product ID 69292-265_e96671e2-f7a8-4d58-8b7f-35b9b7fab5a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076963
Listing Expiration 2026-12-31
Marketing Start 2022-07-26

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 69292265
Hyphenated Format 69292-265

Supplemental Identifiers

RxCUI
1000913
UPC
0369292265017
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 pilocarpine hydrochloride (source: ndc)
Generic Name pilocarpine hydrochloride (source: ndc)
Application Number ANDA076963 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69292-265-01)
source: ndc

Packages (1)

69292-265-01 100 TABLET, FILM COATED in 1 BOTTLE (69292-265-01)

Ingredients (1)

pilocarpine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Pilocarpine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e96671e2-f7a8-4d58-8b7f-35b9b7fab5a6", "openfda": {"upc": ["0369292265017"], "unii": ["0WW6D218XJ"], "rxcui": ["1000913"], "spl_set_id": ["a86a7b63-5f6a-4c10-9270-24c7b7d50437"], "manufacturer_name": ["AMICI PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69292-265-01)", "package_ndc": "69292-265-01", "marketing_start_date": "20220726"}], "brand_name": "Pilocarpine Hydrochloride", "product_id": "69292-265_e96671e2-f7a8-4d58-8b7f-35b9b7fab5a6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "69292-265", "generic_name": "PILOCARPINE HYDROCHLORIDE", "labeler_name": "AMICI PHARMACEUTICALS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pilocarpine Hydrochloride", "active_ingredients": [{"name": "PILOCARPINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA076963", "marketing_category": "ANDA", "marketing_start_date": "20220726", "listing_expiration_date": "20261231"}