FDA Orange Book

Generic for Wellbutrin SR

Wellbutrin SR contains bupropion. 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 Wellbutrin SR is bupropion. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3. Generics match 3 of the 4 Wellbutrin SR products the Orange Book lists.

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Wellbutrin SR products in the Orange Book

Wellbutrin SR products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, extended release, oral100MGMarketed (Rx)AB112AB1
tablet, extended release, oral150MGMarketed (Rx)AB132AB1, AB2, AB3
tablet, extended release, oral200MGMarketed (Rx)AB111AB1
tablet, extended release, oral50MGDiscontinuedNone0None

NDA 020358, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic bupropion

Approved generic versions of Wellbutrin SR
CompanyANDATE codeApprovedStrengths
EPIC PHARMA LLC075932AB1 (A-rated, therapeutically equivalent)November 25, 2003100MG, 150MG, 200MG
IMPAX LABORATORIES INC075913AB1 (A-rated, therapeutically equivalent)January 28, 2004100MG, 150MG
IMPAX LABORATORIES INC075914AB2 (A-rated, therapeutically equivalent)May 27, 2004150MG
SANDOZ INC077475AB2 (A-rated, therapeutically equivalent)March 12, 2008150MG
ACTAVIS LABORATORIES FL INC077715AB3 (A-rated, therapeutically equivalent)November 26, 2008150MG
WATSON LABORATORIES INC077285AB3 (A-rated, therapeutically equivalent)November 26, 2008150MG
ACTAVIS LABORATORIES FL INC079095AB1 (A-rated, therapeutically equivalent)March 24, 2009100MG, 150MG, 200MG
ACTAVIS LABORATORIES FL INC079094AB2 (A-rated, therapeutically equivalent)March 24, 2009150MG
AUROBINDO PHARMA USA INC090325AB1 (A-rated, therapeutically equivalent)April 8, 2010100MG, 150MG, 200MG
WOCKHARDT LTD202189AB3 (A-rated, therapeutically equivalent)November 21, 2012150MG
PRINSTON PHARMACEUTICAL INC202304AB1 (A-rated, therapeutically equivalent)May 26, 2015100MG, 150MG, 200MG
SCIEGEN PHARMACEUTICALS INC205794AB1 (A-rated, therapeutically equivalent)March 1, 2016100MG, 150MG, 200MG
SCIEGEN PHARMACEUTICALS INC206122AB2 (A-rated, therapeutically equivalent)August 17, 2016150MG
LUPIN LTD090693AB3 (A-rated, therapeutically equivalent)April 6, 2017150MG
SCIEGEN PHARMACEUTICALS INC207479AB3 (A-rated, therapeutically equivalent)April 12, 2017150MG
ANBISON LABORATORY CO LTD207224AB3 (A-rated, therapeutically equivalent)June 30, 2017150MG
SINOTHERAPEUTICS INC208652AB3 (A-rated, therapeutically equivalent)August 21, 2017150MG
YICHANG HUMANWELL PHARMACEUTICAL CO LTD210015AB3 (A-rated, therapeutically equivalent)June 14, 2018150MG
ZYDUS PHARMACEUTICALS USA INC201567AB3 (A-rated, therapeutically equivalent)July 23, 2018150MG
YICHANG HUMANWELL PHARMACEUTICAL CO LTD211347AB1 (A-rated, therapeutically equivalent)October 16, 2018100MG, 150MG, 200MG
ACCORD HEALTHCARE INC210497AB3 (A-rated, therapeutically equivalent)October 31, 2018150MG
GRAVITI PHARMACEUTICALS PRIVATE LTD211020AB3 (A-rated, therapeutically equivalent)January 28, 2019150MG
ZHEJIANG JUTAI PHARMACEUTICAL CO LTD211200AB3 (A-rated, therapeutically equivalent)April 29, 2020150MG
GRANULES PHARMACEUTICALS INC215568AB3 (A-rated, therapeutically equivalent)February 2, 2022150MG
YICHANG HUMANWELL PHARMACEUTICAL CO LTD216766AB2 (A-rated, therapeutically equivalent)January 9, 2023150MG
ANNORA PHARMA PRIVATE LTD216800AB1 (A-rated, therapeutically equivalent)May 31, 2023100MG, 200MG
GRANULES PHARMACEUTICALS INC218385AB1 (A-rated, therapeutically equivalent)October 17, 2024100MG, 200MG
IPCA LABORATORIES LTD207874AB1 (A-rated, therapeutically equivalent)May 2, 2025100MG, 200MG
YICHANG HUMANWELL PHARMACEUTICAL CO LTD220529AB1 (A-rated, therapeutically equivalent)May 4, 2026100MG, 200MG
MACLEODS PHARMACEUTICALS LTD218567AB1 (A-rated, therapeutically equivalent)June 23, 2026100MG, 200MG

Wellbutrin SR NDC codes

Questions

Is there a generic for Wellbutrin SR?

Yes. The generic name for Wellbutrin SR is bupropion. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3. Generics match 3 of the 4 Wellbutrin SR products the Orange Book lists.

What is the generic name for Wellbutrin SR?

The active ingredient in Wellbutrin SR is bupropion, 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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