pilocarpine hydrochloride

Generic: pilocarpine hydrochloride ophthalmic solution

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pilocarpine hydrochloride
Generic Name pilocarpine hydrochloride ophthalmic solution
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

pilocarpine hydrochloride 40 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-201
Product ID 70069-201_82a2d0b0-5ac5-46a1-b945-1f5669cc75ec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210384
Listing Expiration 2027-12-31
Marketing Start 2019-11-25

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 70069201
Hyphenated Format 70069-201

Supplemental Identifiers

RxCUI
1000647 1000862 1000897
UPC
0370069191019 0370069201015 0370069181010
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 ophthalmic solution (source: ndc)
Application Number ANDA210384 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-201-01) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-201-01 1 BOTTLE in 1 CARTON (70069-201-01) / 15 mL in 1 BOTTLE

Ingredients (1)

pilocarpine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

Pilocarpine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "82a2d0b0-5ac5-46a1-b945-1f5669cc75ec", "openfda": {"upc": ["0370069191019", "0370069201015", "0370069181010"], "unii": ["0WW6D218XJ"], "rxcui": ["1000647", "1000862", "1000897"], "spl_set_id": ["84428e9a-f486-44d9-ad93-4ea9069a6787"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-201-01)  / 15 mL in 1 BOTTLE", "package_ndc": "70069-201-01", "marketing_start_date": "20191125"}], "brand_name": "Pilocarpine Hydrochloride", "product_id": "70069-201_82a2d0b0-5ac5-46a1-b945-1f5669cc75ec", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "70069-201", "generic_name": "Pilocarpine Hydrochloride Ophthalmic Solution", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pilocarpine Hydrochloride", "active_ingredients": [{"name": "PILOCARPINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "ANDA210384", "marketing_category": "ANDA", "marketing_start_date": "20191125", "listing_expiration_date": "20271231"}