Ortho Tri Cyclen

Product NDC
50458-191
11-digit product format
504580191
Labeler code
50458
Product ID
50458-191_54d9c150-b6a2-11ec-9a5d-8e7b1acbdaa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA019697
Marketing category
NDA
Marketing start
1989-12-29
Marketing end
0000-00-00
Active strength
0
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
50458-191-06EA - Each50458-1915ce78850-01f2-4f6d-aefe-74b2d5cc621a12018-05-09
50458-191-12EA - Each50458-1910575d4b4-59b6-404b-9aee-27c3074abe4312018-05-09
50458-191-15EA - Each50458-1915daf759e-1aa4-40a3-8a7f-3084ba0c717d12012-07-24
50458-191-20EA - Each50458-191d8d22b00-ebb5-4c87-9777-7e5bcbc85c1c12017-11-06
50458-191-28EA - Each50458-191cfea3095-c595-4662-bfbc-a644ad6b878a12018-06-11