FDA Orange Book
Generic for Monodox
Monodox contains doxycycline. 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 Monodox is doxycycline. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Monodox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Marketed (Rx) | AB | 6 | AB |
| capsule, oral | EQ 150MG BASE | Marketed (Rx) | AB | 1 | AB |
| capsule, oral | EQ 50MG BASE | Marketed (Rx) | AB | 5 | AB |
| capsule, oral | EQ 75MG BASE | Marketed (Rx) | AB | 5 | AB |
NDA 050641, held by CHARTWELL RX SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxycycline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LTD | 065053 | AB (A-rated, therapeutically equivalent) | November 22, 2000 | EQ 100MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| STRIDES PHARMA INTERNATIONAL AG | 065055 | AB (A-rated, therapeutically equivalent) | December 1, 2000 | EQ 100MG BASE, EQ 150MG BASE, EQ 50MG BASE |
| LUPIN LTD | 204234 | AB (A-rated, therapeutically equivalent) | March 5, 2014 | EQ 100MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 205115 | AB (A-rated, therapeutically equivalent) | February 18, 2016 | EQ 100MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 209165 | AB (A-rated, therapeutically equivalent) | July 28, 2017 | EQ 100MG BASE, EQ 75MG BASE |
| DR REDDYS LABORATORIES SA | 209396 | AB (A-rated, therapeutically equivalent) | September 29, 2017 | EQ 100MG BASE, EQ 50MG BASE, EQ 75MG BASE |
Monodox NDC codes
Questions
Is there a generic for Monodox?
Yes. The generic name for Monodox is doxycycline. 6 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 Monodox?
The active ingredient in Monodox is doxycycline, 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.