FDA Orange Book
Generic for Cafcit
Cafcit contains caffeine. 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 Cafcit is caffeine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
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Cafcit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | Marketed (Rx) | AP | 5 | AP |
| solution, oral | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | Discontinued | None | 4 | AA |
NDA 020793, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic caffeine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EXELA PHARMA SCIENCES | 077233 | AP (A-rated, therapeutically equivalent) | September 21, 2006 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| EXELA PHARMA SCIENCES LLC | 077304 | AA (A-rated, therapeutically equivalent) | September 21, 2006 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| AMERICAN REGENT INC | 077906 | AP (A-rated, therapeutically equivalent) | May 15, 2007 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| FRESENIUS KABI USA LLC | 077997 | AP (A-rated, therapeutically equivalent) | July 20, 2007 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| FRESENIUS KABI USA LLC | 078002 | AA (A-rated, therapeutically equivalent) | January 31, 2008 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| SAGENT PHARMACEUTICALS INC | 090827 | AP (A-rated, therapeutically equivalent) | August 29, 2012 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| SAGENT PHARMACEUTICALS INC | 091102 | AA (A-rated, therapeutically equivalent) | August 29, 2012 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| MICRO LABS LTD | 207400 | AP (A-rated, therapeutically equivalent) | December 14, 2017 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| MICRO LABS LTD | 213202 | AA (A-rated, therapeutically equivalent) | December 16, 2019 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Cafcit NDC codes
Questions
Is there a generic for Cafcit?
Yes. The generic name for Cafcit is caffeine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
What is the generic name for Cafcit?
The active ingredient in Cafcit is caffeine, 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.