alcaftadine

Generic: alcaftadine

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

Drug Facts

Product Profile

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

alcaftadine 2.5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-649
Product ID 68083-649_8c937f90-5ae8-49e9-808d-f3dbd9da1882
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209706
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Pharmacologic Class

Established (EPC)
histamine-1 receptor antagonist [epc]
Mechanism of Action
histamine h1 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083649
Hyphenated Format 68083-649

Supplemental Identifiers

RxCUI
1000085
UNII
7Z8O94ECSX
NUI
N0000000190 N0000175587

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 alcaftadine (source: ndc)
Generic Name alcaftadine (source: ndc)
Application Number ANDA209706 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLE
source: ndc

Packages (2)

68083-649-01 1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE 68083-649-02 2 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLE

Ingredients (1)

alcaftadine (2.5 mg/mL)

Linked Drug Pages (1)

Alcaftadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "8c937f90-5ae8-49e9-808d-f3dbd9da1882", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["7Z8O94ECSX"], "rxcui": ["1000085"], "spl_set_id": ["b94e071d-421d-48ec-a4ea-254aa8af19ff"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68083-649-01)  / 3 mL in 1 BOTTLE", "package_ndc": "68083-649-01", "marketing_start_date": "20240301"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (68083-649-02)  / 3 mL in 1 BOTTLE", "package_ndc": "68083-649-02", "marketing_start_date": "20240301"}], "brand_name": "Alcaftadine", "product_id": "68083-649_8c937f90-5ae8-49e9-808d-f3dbd9da1882", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68083-649", "generic_name": "Alcaftadine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Alcaftadine", "active_ingredients": [{"name": "ALCAFTADINE", "strength": "2.5 mg/mL"}], "application_number": "ANDA209706", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}