FDA Orange Book

Generic for Emerphed

Emerphed contains ephedrine. 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 Emerphed is ephedrine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2, AP3.

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Emerphed products in the Orange Book

Emerphed products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, intravenous	25MG/5ML (5MG/ML)	Marketed (Rx)	None	2	AP3, AP2
solution, intravenous	50MG/10ML (5MG/ML)	Marketed (Rx)	AP1	3	AP1, AP2

NDA 213407, held by NEXUS PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ephedrine

Approved generic versions of Emerphed
Company	ANDA	TE code	Approved	Strengths
HIKMA PHARMACEUTICALS USA INC	217721	AP3 (A-rated, therapeutically equivalent)	October 11, 2024	25MG/5ML (5MG/ML)
GLAND PHARMA LTD	218211	AP1 (A-rated, therapeutically equivalent)	January 16, 2025	50MG/10ML (5MG/ML)
FRESENIUS KABI USA LLC	218271	AP2 (A-rated, therapeutically equivalent)	March 11, 2025	25MG/5ML (5MG/ML), 50MG/10ML (5MG/ML)
FRESENIUS KABI USA LLC	219991	AP2 (A-rated, therapeutically equivalent)	March 19, 2026	50MG/10ML (5MG/ML)

Emerphed patents

Patents listed for Emerphed
Patent	Expires	Covers	Use code	NDA
11571398	May 16, 2040	Method of use	U-3183	213407
11464752	May 16, 2040	Drug product	None	213407
11478436	May 16, 2040	Method of use	U-3183	213407
11090278	May 16, 2040	Method of use	U-3183	213407
11241400	May 16, 2040	Method of use	U-3183	213407

Emerphed NDC codes

Questions

Is there a generic for Emerphed?

Yes. The generic name for Emerphed is ephedrine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2, AP3.

What is the generic name for Emerphed?

The active ingredient in Emerphed is ephedrine, per the FDA Orange Book.

When does the Emerphed patent expire?

The last patent listed for Emerphed in the Orange Book expires May 16, 2040. 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.