FDA Orange Book
Generic for Celestone Soluspan
Celestone Soluspan contains betamethasone and betamethasone acetate. 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 Celestone Soluspan is betamethasone and betamethasone acetate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Celestone Soluspan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 3MG/ML;EQ 3MG BASE/ML | Marketed (Rx) | AB | 2 | AB |
NDA 014602, held by ORGANON LLC A SUB OF ORGANON AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic betamethasone and betamethasone acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMERICAN REGENT INC | 090747 | AB (A-rated, therapeutically equivalent) | July 31, 2009 | 3MG/ML;EQ 3MG BASE/ML |
| HIKMA FARMACEUTICA PORTUGAL SA | 077838 | AB (A-rated, therapeutically equivalent) | January 17, 2023 | 3MG/ML;EQ 3MG BASE/ML |
Celestone Soluspan NDC codes
Questions
Is there a generic for Celestone Soluspan?
Yes. The generic name for Celestone Soluspan is betamethasone and betamethasone acetate. 2 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 Celestone Soluspan?
The active ingredient in Celestone Soluspan is betamethasone and betamethasone acetate, 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.