bimatoprost

Generic: bimatoprost

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bimatoprost
Generic Name bimatoprost
Labeler apotex corp.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bimatoprost .3 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0583
Product ID 60505-0583_69038a16-abb9-042d-c9ac-f8727040607f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090449
Listing Expiration 2026-12-31
Marketing Start 2018-10-08

Pharmacologic Class

Established (EPC)
prostaglandin analog [epc]
Chemical Structure
prostaglandins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050583
Hyphenated Format 60505-0583

Supplemental Identifiers

RxCUI
308739
UNII
QXS94885MZ
NUI
N0000175454 M0017805

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 bimatoprost (source: ndc)
Generic Name bimatoprost (source: ndc)
Application Number ANDA090449 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0583-1) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60505-0583-4) / 2.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

60505-0583-1 1 BOTTLE, DROPPER in 1 CARTON (60505-0583-1) / 5 mL in 1 BOTTLE, DROPPER 60505-0583-4 1 BOTTLE, DROPPER in 1 CARTON (60505-0583-4) / 2.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bimatoprost (.3 mg/mL)

Linked Drug Pages (1)

Bimatoprost ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "69038a16-abb9-042d-c9ac-f8727040607f", "openfda": {"nui": ["N0000175454", "M0017805"], "unii": ["QXS94885MZ"], "rxcui": ["308739"], "spl_set_id": ["f5c1c8c6-2a7f-482b-6ecf-9cabd3a6a5c1"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0583-1)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0583-1", "marketing_start_date": "20181008"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60505-0583-4)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60505-0583-4", "marketing_start_date": "20181008"}], "brand_name": "Bimatoprost", "product_id": "60505-0583_69038a16-abb9-042d-c9ac-f8727040607f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Prostaglandin Analog [EPC]", "Prostaglandins [CS]"], "product_ndc": "60505-0583", "generic_name": "Bimatoprost", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bimatoprost", "active_ingredients": [{"name": "BIMATOPROST", "strength": ".3 mg/mL"}], "application_number": "ANDA090449", "marketing_category": "ANDA", "marketing_start_date": "20181008", "listing_expiration_date": "20261231"}