FDA Orange Book
Generic for Vancocin Hydrochloride
Vancocin Hydrochloride contains vancomycin. 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 Vancocin Hydrochloride is vancomycin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Vancocin Hydrochloride products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 125MG BASE | Marketed (Rx) | AB | 3 | AB |
| capsule, oral | EQ 250MG BASE | Marketed (Rx) | AB | 3 | AB |
NDA 050606, held by ANI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic vancomycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA | 065478 | AB (A-rated, therapeutically equivalent) | April 9, 2012 | EQ 125MG BASE, EQ 250MG BASE |
| STRIDES PHARMA GLOBAL PTE LTD | 065490 | AB (A-rated, therapeutically equivalent) | April 9, 2012 | EQ 125MG BASE, EQ 250MG BASE |
| ORIENT PHARMA CO LTD | 210729 | AB (A-rated, therapeutically equivalent) | April 29, 2019 | EQ 125MG BASE, EQ 250MG BASE |
Vancocin Hydrochloride NDC codes
Questions
Is there a generic for Vancocin Hydrochloride?
Yes. The generic name for Vancocin Hydrochloride is vancomycin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Vancocin Hydrochloride?
The active ingredient in Vancocin Hydrochloride is vancomycin, 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.