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LASTACAFT

These highlights do not include all the information needed to use LASTACAFT safely and effectively. See full prescribing information for LASTACAFT. LASTACAFT (alcaftadine ophthalmic solution) 0.25%Initial U.S. Approval: 2010

Approved
Approval ID

4b8c6afe-2d76-46c7-a23e-99db5e180ff6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 5, 2012

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

alcaftadine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42254-288
Application NumberNDA022134
Product Classification
M
Marketing Category
C73594
G
Generic Name
alcaftadine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 30, 2010
FDA Product Classification

INGREDIENTS (8)

waterInactive
Code: 059QF0KO0R
Classification: IACT
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
alcaftadineActive
Quantity: 2.5 mg in 1 mL
Code: 7Z8O94ECSX
Classification: ACTIB
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SW
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/12/2011

1 INDICATIONS AND USAGE

LASTACAFT**®** is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

Key Highlight

LASTACAFT**®** is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. (1)

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 9/30/2010

4 CONTRAINDICATIONS

None.

DOSAGE FORMS & STRENGTHS SECTION

LOINC: 43678-2Updated: 9/30/2010

3 DOSAGE FORMS AND STRENGTHS

Topical ophthalmic solution containing alcaftadine, 0.25% (2.5 mg/mL).

Key Highlight

Ophthalmic solution containing alcaftadine, 0.25% (2.5 mg/mL) (3)

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