FDA Orange Book
Generic for Lac-hydrin
Lac-hydrin contains ammonium lactate. 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 Lac-hydrin is ammonium lactate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Lac-hydrin and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Lac-hydrin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 12% BASE | Discontinued | None | 3 | AB |
| lotion, topical | EQ 12% BASE | Discontinued | None | 3 | AB |
NDA 020508, 019155, held by SUN PHARMACEUTICAL INDUSTRIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ammonium lactate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 075774 | AB (A-rated, therapeutically equivalent) | May 1, 2002 | EQ 12% BASE |
| SUN PHARMA CANADA INC | 075883 | AB (A-rated, therapeutically equivalent) | April 10, 2003 | EQ 12% BASE |
| SUN PHARMA CANADA INC | 076216 | AB (A-rated, therapeutically equivalent) | May 28, 2004 | EQ 12% BASE |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 075570 | AB (A-rated, therapeutically equivalent) | June 23, 2004 | EQ 12% BASE |
| ZYDUS LIFESCIENCES LTD | 217815 | AB (A-rated, therapeutically equivalent) | February 12, 2026 | EQ 12% BASE |
| ZYDUS LIFESCIENCES LTD | 217758 | AB (A-rated, therapeutically equivalent) | May 15, 2026 | EQ 12% BASE |
Questions
Is there a generic for Lac-hydrin?
Yes. The generic name for Lac-hydrin is ammonium lactate. 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 Lac-hydrin?
The active ingredient in Lac-hydrin is ammonium lactate, 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.