FDA Orange Book

Generic for Adenocard

Adenocard contains adenosine. 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 Adenocard is adenosine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Adenocard products in the Orange Book

Adenocard products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection3MG/MLDiscontinuedNone8AP

NDA 019937, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic adenosine

Approved generic versions of Adenocard
CompanyANDATE codeApprovedStrengths
HIKMA PHARMACEUTICALS USA INC076404AP (A-rated, therapeutically equivalent)June 16, 20043MG/ML
HIKMA PHARMACEUTICALS USA INC076500AP (A-rated, therapeutically equivalent)June 16, 20043MG/ML
FRESENIUS KABI USA LLC077133AP (A-rated, therapeutically equivalent)April 27, 20053MG/ML
GLAND PHARMA LTD077283AP (A-rated, therapeutically equivalent)June 14, 20073MG/ML
RISING PHARMA HOLDINGS INC078076AP (A-rated, therapeutically equivalent)October 31, 20083MG/ML
MYLAN LABORATORIES LTD078686AP (A-rated, therapeutically equivalent)May 13, 20093MG/ML
GLAND PHARMA LTD206778AP (A-rated, therapeutically equivalent)February 16, 20183MG/ML
FRESENIUS KABI USA LLC205568AP (A-rated, therapeutically equivalent)April 16, 20183MG/ML

Questions

Is there a generic for Adenocard?

Yes. The generic name for Adenocard is adenosine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Adenocard?

The active ingredient in Adenocard is adenosine, 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.

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