UPNEEQ
These highlights do not include all the information needed to use UPNEEQ safely and effectively. See full prescribing information for UPNEEQ. UPNEEQ (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for topical ophthalmic useInitial U.S. Approval: 1964
Approved
Approval ID
cf6c9a1f-2367-46d2-99c3-c7d67ec6f519
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2023
Manufacturers
FDA
RVL Pharmaceuticals, Inc.
DUNS: 081365086
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxymetazoline hydrochloride ophthalmic
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73687-062
Application NumberNDA212520
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxymetazoline hydrochloride ophthalmic
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 9, 2023
FDA Product Classification
INGREDIENTS (10)
OXYMETAZOLINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: K89MJ0S5VY
Classification: ACTIB
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT