Register entry

Spirit Pharmaceuticals LLC

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Registered sites
0
Active NDC listings
16
Labeller names
4
Live patents
0
Countries
0
Catalogue

Drug listings by form and route

16

16 active NDC listings: 15 human otc drug, 1 drug for further processing. By marketing category: ANDA 15, DRUG FOR FURTHER PROCESSING 1.

Dosage formNDCs
tablet, film coated12
capsule, liquid filled2
tablet1
tablet, film coated, extended release1
RouteNDCs
oral15
Labeller name on the listingNDCs
spirit pharmaceutical llc7
spirit pharmaceuticals llc3
spirit pharmaceuticals llc3
spirit pharmaceuticals,llc3
Catalogue

Marketed products

16
BrandGeneric nameForm / routeNDC
Allergy ReliefCetirizine Hydrochloridetablet, film coated, oral68210-4219ANDA
Allergy ReliefCetirizine Hydrochloridetablet, film coated, oral68210-4230ANDA
Assured IbuprofenIbuprofentablet, film coated, oral68210-4139ANDA
CABINET Allergy ReliefCetirizine Hydrochloridetablet, film coated, oral68210-0119ANDA
Cabinet Pain Reliever and Fever ReducerIbuprofentablet, film coated, oral68210-0026ANDA
-DEXTROMETHORPHAN HYDROBROMIDEcapsule, liquid filled68210-0121DRUG FOR FURTHER PROCESSING
Fexofenadine HydrochlorideFexofenadine Hydrochloridetablet, film coated, oral68210-2210ANDA
Fexofenadine HydrochlorideFexofenadine Hydrochloridetablet, film coated, oral68210-4090ANDA
IBUPROFENIBUPROFENcapsule, liquid filled, oral68210-0200ANDA
IbuprofenIbuprofentablet, film coated, oral68210-4140ANDA
IbuprofenIbuprofentablet, film coated, oral68210-4192ANDA
IbuprofenIbuprofentablet, film coated, oral68210-6114ANDA
IbuprofenIbuprofentablet, film coated, oral68210-8100ANDA
LoratadineLoratadinetablet, oral68210-4110ANDA
NAPROXEN SODIUMNAPROXEN SODIUMtablet, film coated, extended release, oral68210-4096ANDA
VALUMEDS IBUPROFENIBUPROFENtablet, film coated, oral68210-0800ANDA
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Other companies listing ibuprofen

Enquiry

Common questions

Is Spirit Pharmaceuticals LLC FDA approved?
Spirit Pharmaceuticals LLC holds no registered establishment of its own; 16 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Spirit Pharmaceuticals LLC make?
16 products are listed under Spirit Pharmaceuticals LLC in the openFDA NDC Directory, most often as tablet, film coated; capsule, liquid filled; tablet. 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.