CLARINEX-D 12 HOUR
These highlights do not include all the information needed to use CLARINEX-D 12 HOUR Extended Release Tablets safely and effectively. See full prescribing information for CLARINEX-D 12 HOUR Extended Release Tablets. CLARINEX-D 12 HOUR Extended Release Tablets (desloratadine/pseudoephedrine sulfate) for oral use Initial U.S. Approval: 2005
Approved
Approval ID
1af66b7a-4ab8-40d8-abdd-22d3310228a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2022
Manufacturers
FDA
Organon LLC
DUNS: 117494753
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
desloratadine and pseudoephedrine sulfate
PRODUCT DETAILS
NDC Product Code78206-120
Application NumberNDA021313
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJune 1, 2021
Generic Namedesloratadine and pseudoephedrine sulfate
INGREDIENTS (13)
desloratadineActive
Quantity: 2.5 mg in 1 1
Code: FVF865388R
Classification: ACTIB
pseudoephedrine sulfateActive
Quantity: 120 mg in 1 1
Code: Y9DL7QPE6B
Classification: ACTIB
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT