FDA Orange Book

Generic for Vigamox

Vigamox contains moxifloxacin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Vigamox is moxifloxacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1.

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Vigamox products in the Orange Book

Vigamox products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution/drops, ophthalmicEQ 0.5% BASEMarketed (Rx)AT110AT1

NDA 021598, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic moxifloxacin

Approved generic versions of Vigamox
CompanyANDATE codeApprovedStrengths
LUPIN LTD202867AT1 (A-rated, therapeutically equivalent)September 4, 2014EQ 0.5% BASE
REGCON HOLDINGS LLC202525AT1 (A-rated, therapeutically equivalent)March 6, 2015EQ 0.5% BASE
LUPIN LTD204079None (No TE code listed)May 28, 2015EQ 0.5% BASE
APOTEX INC090080AT1 (A-rated, therapeutically equivalent)June 30, 2017EQ 0.5% BASE
EUGIA PHARMA SPECIALITIES LTD206242AT1 (A-rated, therapeutically equivalent)October 4, 2017EQ 0.5% BASE
ALEMBIC PHARMACEUTICALS LTD209469AT1 (A-rated, therapeutically equivalent)February 13, 2019EQ 0.5% BASE
GLAND PHARMA LTD208778AT1 (A-rated, therapeutically equivalent)March 30, 2020EQ 0.5% BASE
UPSHER SMITH LABORATORIES LLC212616AT1 (A-rated, therapeutically equivalent)February 10, 2021EQ 0.5% BASE
SOMERSET THERAPEUTICS LLC209698AT1 (A-rated, therapeutically equivalent)November 14, 2024EQ 0.5% BASE
MANKIND PHARMA LTD217988AT1 (A-rated, therapeutically equivalent)January 27, 2025EQ 0.5% BASE

Vigamox NDC codes

Questions

Is there a generic for Vigamox?

Yes. The generic name for Vigamox is moxifloxacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1.

What is the generic name for Vigamox?

The active ingredient in Vigamox is moxifloxacin, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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