alcaftadine

Generic: alcaftadine

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alcaftadine
Generic Name alcaftadine
Labeler alembic pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

alcaftadine 2.5 mg/mL

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-147
Product ID 62332-147_64d45e8d-158b-42f2-84aa-14fc849eaf0e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209290
Listing Expiration 2026-12-31
Marketing Start 2024-10-02

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 62332147
Hyphenated Format 62332-147

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 ANDA209290 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (62332-147-03) / 3 mL in 1 BOTTLE
source: ndc

Packages (1)

62332-147-03 1 BOTTLE in 1 CARTON (62332-147-03) / 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": "64d45e8d-158b-42f2-84aa-14fc849eaf0e", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["7Z8O94ECSX"], "rxcui": ["1000085"], "spl_set_id": ["22473109-dc9e-45b6-b188-d7d5773f5a14"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (62332-147-03)  / 3 mL in 1 BOTTLE", "package_ndc": "62332-147-03", "marketing_start_date": "20241002"}], "brand_name": "alcaftadine", "product_id": "62332-147_64d45e8d-158b-42f2-84aa-14fc849eaf0e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "62332-147", "generic_name": "alcaftadine", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "alcaftadine", "active_ingredients": [{"name": "ALCAFTADINE", "strength": "2.5 mg/mL"}], "application_number": "ANDA209290", "marketing_category": "ANDA", "marketing_start_date": "20241002", "listing_expiration_date": "20261231"}