Topcare nicotine

Product NDC
36800-854
11-digit product format
368000854
Labeler code
36800
Product ID
36800-854_d9862828-d387-4f86-9a78-e2ba24f82f5b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA078546
Marketing category
ANDA
Marketing start
2010-01-28
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
4 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-854-78EA - Each36800-854a9c62832-4c02-443f-a9da-5598c41fb7f712012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-854-603680008546020 BLISTER PACK in 1 CARTON (36800-854-60) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2016-10-100000-00-00NoNoCurrent
36800-854-7836800085478100 BLISTER PACK in 1 CARTON (36800-854-78) > 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2010-01-280000-00-00NoNoCurrent