FDA Orange Book
Generic for Cephulac
Cephulac 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 Cephulac is lactulose. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Cephulac products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral, rectal | 10GM/15ML | Discontinued | None | 4 | AA |
NDA 017657, 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 |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 074603 | AA (A-rated, therapeutically equivalent) | October 31, 1996 | 10GM/15ML |
| BAJAJ MEDICAL | 076645 | AA (A-rated, therapeutically equivalent) | July 28, 2003 | 10GM/15ML |
| FRESENIUS KABI AUSTRIA GMBH | 090502 | AA (A-rated, therapeutically equivalent) | January 25, 2012 | 10GM/15ML |
| PHARMAZONE | 203762 | AA (A-rated, therapeutically equivalent) | March 27, 2015 | 10GM/15ML |
Questions
Is there a generic for Cephulac?
Yes. The generic name for Cephulac is lactulose. 4 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 Cephulac?
The active ingredient in Cephulac 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.