FDA Orange Book · active-ingredient family
Pseudoephedrine hydrochloride
Pseudoephedrine hydrochloride is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SUDAFED 24 HOUR · NDA 020021
3
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUDAFED 24 HOURRLD | KENVUE BRANDS | NDA 020021 | — | Dec 15, 1992 | |
| SUDAFED 12 HOURRLD | GLAXOSMITHKLINE | NDA 017941 | — | Approved Prior to Jan 1, 1982 | |
| NOVAFED | SANOFI AVENTIS US | NDA 017603 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 218854 | — | Dec 29, 2025 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 209008 | — | Jun 09, 2017 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | SUN PHARM INDS LTD | ANDA 077442 | — | Sep 28, 2005 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | L PERRIGO CO | ANDA 075153 | — | Feb 26, 1999 | |
| SUDAFED 12 HOUR | MCNEIL CONS | ANDA 073585 | — | Oct 31, 1991 |
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.
Pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
