FDA Orange Book
Generic for Nulytely
Nulytely contains polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride. 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 Nulytely is polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Nulytely products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | Marketed (Rx) | AA | 3 | AA |
NDA 019797, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA USA INC | 076491 | AA (A-rated, therapeutically equivalent) | February 5, 2004 | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
| NOVEL LABORATORIES INC | 090019 | AA (A-rated, therapeutically equivalent) | May 27, 2009 | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
| STRIDES PHARMA GLOBAL PTE LTD | 204559 | AA (A-rated, therapeutically equivalent) | April 13, 2015 | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Nulytely NDC codes
Questions
Is there a generic for Nulytely?
Yes. The generic name for Nulytely is polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride. 3 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 Nulytely?
The active ingredient in Nulytely is polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride, 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.