Orange Book product · Generic (ANDA)
TAPENTADOL HYDROCHLORIDE
TAPENTADOL HYDROCHLORIDE
At a glance
Feb 10, 2026
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 10, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
TAPENTADOL HYDROCHLORIDE
Strength
EQ 50MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 205057
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TAPENTADOL HYDROCHLORIDE
- 2012NUCYNTABrand (NDA)
NDA 203794 · COLLEGIUM PHARM INC
- 2011NUCYNTA ERBrand (NDA)
NDA 200533 · COLLEGIUM PHARM INC
- 2008NUCYNTABrand (NDA)
NDA 022304 · COLLEGIUM PHARM INC
- 2026TAPENTADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 214378 · EPIC PHARMA LLC
- 2026TAPENTADOL HYDROCHLORIDEGeneric (ANDA)
ANDA 219119 · NOVITIUM PHARMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
