FDA Orange Book
Generic for Gastrografin
Gastrografin contains diatrizoate. 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 Gastrografin is diatrizoate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Gastrografin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral, rectal | 66%;10% | Marketed (Rx) | AA | 3 | AA |
NDA 011245, held by BRACCO DIAGNOSTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diatrizoate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ADAPTIS PHARMA PRIVATE LTD | 214201 | AA (A-rated, therapeutically equivalent) | June 27, 2022 | 66%;10% |
| ANNORA PHARMA PRIVATE LTD | 215049 | AA (A-rated, therapeutically equivalent) | November 17, 2023 | 66%;10% |
| LIEBEL-FLARSHEIM CO LLC | 087388 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 66%;10% |
Gastrografin NDC codes
Questions
Is there a generic for Gastrografin?
Yes. The generic name for Gastrografin is diatrizoate. 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 Gastrografin?
The active ingredient in Gastrografin is diatrizoate, 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.