RHOFADE

Product NDC
0023-5300
11-digit product format
000235300
Labeler code
0023
Product ID
0023-5300_1acd8f72-9d36-4756-a3b0-3e354f12d7b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Allergan, Inc.
Application
NDA208552
Marketing category
NDA
Marketing start
2017-01-18
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
10 mg/g
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-5300-30GM - Gram0023-53007bb75572-3170-4eda-b4f0-027401face8b12017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-5300-30000235300301 TUBE in 1 CARTON (0023-5300-30) > 30 g in 1 TUBE1 tube2017-01-180000-00-00NoNoCurrent
0023-5300-35000235300351 BOTTLE, PUMP in 1 CARTON (0023-5300-35) > 30 g in 1 BOTTLE, PUMP2017-10-010000-00-00NoNoCurrent
0023-5300-60000235300601 TUBE in 1 CARTON (0023-5300-60) > 60 g in 1 TUBE1 tube2017-01-180000-00-00NoNoCurrent
0023-5300-65000235300651 BOTTLE, PUMP in 1 CARTON (0023-5300-65) > 60 g in 1 BOTTLE, PUMP2017-10-010000-00-00NoNoCurrent