Olopatadine Hydrochloride

Product NDC
64679-363
11-digit product format
646790363
Labeler code
64679
Product ID
64679-363_9f7f79a1-4ed7-4e25-83e7-f4b8e9f2a31f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Wockhardt USA LLC.
Application
ANDA200810
Marketing category
ANDA
Marketing start
2017-06-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64679-363-012024-11-15C16284748780-1d6a99b39-511c-a426-e053-dadaa90af4c2cacc7fef-369e-4871-aeac-ede8ef553034
64679-363-012022-01-28C16284748780-1d6a99b39-511c-a426-e053-dadaa90af4c2cacc7fef-369e-4871-aeac-ede8ef553034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-363-01646790363011 BOTTLE, PLASTIC in 1 CARTON (64679-363-01) > 5 mL in 1 BOTTLE, PLASTIC2017-06-280000-00-00NoNoCurrent