FDA Orange Book
Generic for Chronulac
Chronulac contains lactulose. 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 Chronulac is lactulose. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Chronulac products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 10GM/15ML | Discontinued | None | 8 | AA |
NDA 017884, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lactulose
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMACEUTICAL ASSOCIATES INC | 074623 | AA (A-rated, therapeutically equivalent) | July 30, 1996 | 10GM/15ML |
| AUROBINDO PHARMA LTD | 074602 | AA (A-rated, therapeutically equivalent) | November 14, 1996 | 10GM/15ML |
| LANNETT CO INC | 075993 | AA (A-rated, therapeutically equivalent) | July 26, 2001 | 10GM/15ML |
| PHARMOBEDIENT CONSULTING LLC | 075911 | AA (A-rated, therapeutically equivalent) | February 21, 2002 | 10GM/15ML |
| FRESENIUS KABI AUSTRIA GMBH | 090503 | AA (A-rated, therapeutically equivalent) | January 25, 2012 | 10GM/15ML |
| PHARMAZONE | 207786 | AA (A-rated, therapeutically equivalent) | June 11, 2018 | 10GM/15ML |
| CHARTWELL RX SCIENCES LLC | 209517 | AA (A-rated, therapeutically equivalent) | November 23, 2018 | 10GM/15ML |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 218858 | AA (A-rated, therapeutically equivalent) | December 13, 2024 | 10GM/15ML |
Questions
Is there a generic for Chronulac?
Yes. The generic name for Chronulac is lactulose. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Chronulac?
The active ingredient in Chronulac is lactulose, 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.