Olopatadine Hydrochloride

Product NDC
64980-517
11-digit product format
649800517
Labeler code
64980
Product ID
64980-517_a3f39a66-d9c4-483a-b786-87772d3f8a25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride USP, 0.1%
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA203152
Marketing category
ANDA
Marketing start
2015-12-07
Marketing end
0000-00-00
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-517-05ML - Milliliter64980-5178afcff31-e252-4638-942b-69499e99d89012016-01-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-517-05649800517051 BOTTLE, DROPPER in 1 CARTON (64980-517-05) > 5 mL in 1 BOTTLE, DROPPER2015-12-070000-00-00NoNoCurrent