Is Quitine LLC FDA approved?

Quitine LLC holds no registered establishment of its own; 19 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Quitine LLC make?

19 products are listed under Quitine LLC in the openFDA NDC Directory, most often as gum, chewing; lozenge; patch. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Quitine LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 19
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

19 active NDC listings: 19 human otc drug. By marketing category: ANDA 19.

Dosage form	NDCs
gum, chewing	8
lozenge	8
patch	3

Route	NDCs
oral	16
transdermal	3

Labeller name on the listing	NDCs
quitine llc	14
quitine llc	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Nicotine Polacrilex	Nicotine Polacrilex	gum, chewing, oral	84720-927ANDA
Nicotine Polacrilex	Nicotine Polacrilex	gum, chewing, oral	84720-933ANDA
Nicotine Transdermal System	Nicotine Transdermal System	patch, transdermal	84720-120ANDA
Nicotine Transdermal System	Nicotine Transdermal System	patch, transdermal	84720-121ANDA
Nicotine Transdermal System	Nicotine Transdermal System	patch, transdermal	84720-122ANDA
QUITINE MINI NICOTINE	Nicotine Polacrilex	lozenge, oral	84720-034ANDA
QUITINE NICOTINE	Nicotine polacrilex	gum, chewing, oral	84720-012ANDA
QUITINE NICOTINE	Nicotine Polacrilex	lozenge, oral	84720-190ANDA
QUITINE NICOTINE	nicotine polacrilex	lozenge, oral	84720-222ANDA
Quitine Nicotine	Nicotine Polacrilex	gum, chewing, oral	84720-309ANDA
Quitine Nicotine	nicotine polacrilex	lozenge, oral	84720-400ANDA
Quitine nicotine	Nicotine Polacrilex	lozenge, oral	84720-124ANDA
quitine mini nicotine	Nicotine Polacrilex	lozenge, oral	84720-009ANDA
quitine nicotine	Nicotine Polacrilex	lozenge, oral	84720-000ANDA
quitine nicotine	nicotine polacrilex	lozenge, oral	84720-007ANDA
quitine nicotine	Nicotine Polacrilex	gum, chewing, oral	84720-352ANDA
quitine nicotine	Nicotine Polacrilex	gum, chewing, oral	84720-456ANDA
quitine nicotine	Nicotine Polacrilex	gum, chewing, oral	84720-532ANDA
quitine nicotine	Nicotine polacrilex	gum, chewing, oral	84720-854ANDA

Compare

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Enquiry

Common questions

Is Quitine LLC FDA approved?: Quitine LLC holds no registered establishment of its own; 19 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Quitine LLC make?: 19 products are listed under Quitine LLC in the openFDA NDC Directory, most often as gum, chewing; lozenge; patch. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.