FDA Orange Book

Generic for Nucynta

Nucynta contains tapentadol. 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 Nucynta is tapentadol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Nucynta products in the Orange Book

Nucynta products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
solution, oral	EQ 20MG BASE/ML	Discontinued	None	1	None
tablet, oral	EQ 100MG BASE	Marketed (Rx)	AB	2	AB
tablet, oral	EQ 50MG BASE	Marketed (Rx)	AB	2	AB
tablet, oral	EQ 75MG BASE	Marketed (Rx)	AB	2	AB

NDA 203794, 022304, held by COLLEGIUM PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tapentadol

Approved generic versions of Nucynta
Company	ANDA	TE code	Approved	Strengths
NOVITIUM PHARMA LLC	219119	None (No TE code listed)	January 26, 2026	EQ 20MG BASE/ML
EPIC PHARMA LLC	214378	AB (A-rated, therapeutically equivalent)	January 27, 2026	EQ 100MG BASE, EQ 50MG BASE, EQ 75MG BASE
MSN LABORATORIES PRIVATE LTD	220865	AB (A-rated, therapeutically equivalent)	September 3, 2026	EQ 100MG BASE, EQ 50MG BASE, EQ 75MG BASE

Nucynta exclusivity

Exclusivity listed for Nucynta
Code	Meaning	Expires	NDA
NPP	New patient population	July 3, 2026	203794
PED	Pediatric exclusivity	January 3, 2027	203794

Nucynta NDC codes

Questions

Is there a generic for Nucynta?

Yes. The generic name for Nucynta is tapentadol. 3 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 Nucynta?

The active ingredient in Nucynta is tapentadol, 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.