Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
70677-0122
11-digit product format
706770122
Labeler code
70677
Product ID
70677-0122_46aba295-86cc-338f-4c4e-b9d4d369c2b9
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Strategic Sourcing Specialists, LLC
Application
ANDA209752
Marketing category
ANDA
Marketing start
2021-03-15
Marketing end
0000-00-00
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0122-1ML - Milliliter70677-0122a32f4698-19f8-4cda-804f-147606d3b63e12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0122OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION ONCE DAILY RELIEF (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [STRATEGIC SOURCING SPECIALISTS, LLC]4Legacy NDC20241114_b793e383-5bc7-8e34-78d0-851091f34e31.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70677-0122-1706770122011 BOTTLE, PLASTIC in 1 CARTON (70677-0122-1) > 2.5 mL in 1 BOTTLE, PLASTIC2021-03-150000-00-00NoNoCurrent