FDA Orange Book
Is there a generic for Hemangeol?
Hemangeol contains propranolol. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hemangeol (propranolol). The Orange Book shows its last listed patent expires October 16, 2028.
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Hemangeol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 4.28MG/ML | Marketed (Rx) | None | 0 | None |
NDA 205410, held by ETON PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Hemangeol patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8338489 | October 16, 2028 | Method of use | U-1496 | 205410 |
| 8987262 | October 16, 2028 | Method of use | U-1988 | 205410 |
Hemangeol NDC codes
Questions
Is there a generic for Hemangeol?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hemangeol (propranolol). The Orange Book shows its last listed patent expires October 16, 2028.
What is the generic name for Hemangeol?
The active ingredient in Hemangeol is propranolol, per the FDA Orange Book.
When does the Hemangeol patent expire?
The last patent listed for Hemangeol in the Orange Book expires October 16, 2028. A listed patent expiry date is not a generic launch date.
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.
More on Hemangeol and Propranolol
- What is Propranolol used for?FDA label uses
- Is Propranolol a controlled substance?Federal schedule
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- NDC 64370-375Hemangeol NDC record
- NDC 71863-132Hemangeol NDC record