bimatoprost

Generic: bimatoprost

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bimatoprost
Generic Name bimatoprost
Labeler gland pharma limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bimatoprost .3 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-439
Product ID 68083-439_512bd5c6-1e5d-4423-b06e-9fe80ff833c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210126
Listing Expiration 2026-12-31
Marketing Start 2020-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083439
Hyphenated Format 68083-439

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 ANDA210126 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68083-439-01) / 7.5 mL in 1 BOTTLE
source: ndc

Packages (1)

68083-439-01 1 BOTTLE in 1 CARTON (68083-439-01) / 7.5 mL in 1 BOTTLE

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": "512bd5c6-1e5d-4423-b06e-9fe80ff833c2", "openfda": {"nui": ["N0000175454", "M0017805"], "unii": ["QXS94885MZ"], "rxcui": ["308739"], "spl_set_id": ["2a4b5b6b-fc47-40d2-8396-ff60511a4cd1"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68083-439-01)  / 7.5 mL in 1 BOTTLE", "package_ndc": "68083-439-01", "marketing_start_date": "20200812"}], "brand_name": "Bimatoprost", "product_id": "68083-439_512bd5c6-1e5d-4423-b06e-9fe80ff833c2", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Prostaglandin Analog [EPC]", "Prostaglandins [CS]"], "product_ndc": "68083-439", "generic_name": "Bimatoprost", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bimatoprost", "active_ingredients": [{"name": "BIMATOPROST", "strength": ".3 mg/mL"}], "application_number": "ANDA210126", "marketing_category": "ANDA", "marketing_start_date": "20200812", "listing_expiration_date": "20261231"}