Bepotastine Besilate

Product NDC
60505-6111
11-digit product format
605056111
Labeler code
60505
Product ID
60505-6111_59a86a77-90ac-ef70-22bc-d564452527be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bepotastine Besilate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA206066
Marketing category
ANDA
Marketing start
2021-11-08
Marketing end
2024-08-25
Substance
BEPOTASTINE BESYLATE
Active strength
15 mg/mL
Pharmacologic classes
Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6111-1ML - Milliliter60505-6111ffde1ee2-baff-4143-91b8-871e33cffa9a12021-11-09
60505-6111-2ML - Milliliter60505-61110dfcf859-c857-4c1d-92f8-eefb95e27bb612021-11-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6111-1605056111011 BOTTLE, DROPPER in 1 CARTON (60505-6111-1) > 5 mL in 1 BOTTLE, DROPPER2021-11-082024-08-25NoNoCurrent
60505-6111-2605056111021 BOTTLE, DROPPER in 1 CARTON (60505-6111-2) > 10 mL in 1 BOTTLE, DROPPER2021-11-082024-08-25NoNoCurrent