Mini Nicotine

Product NDC
68016-087
11-digit product format
680160087
Labeler code
68016
Product ID
68016-087_7a4d1ab3-534f-45d3-ac06-d14888fd7c2e
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA207868
Marketing category
ANDA
Marketing start
2019-04-30
Marketing end
2026-12-31
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mini Nicotine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-087-81Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE274
68016-087-81Mini Nicotine3 in 1 BOXLOZENGE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-087MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [CHAIN DRUG CONSORTIUM, LLC]3Current NDC, Legacy NDC, 2 package rows20231007_380ce6c2-3e29-4bdf-a600-f6990925a307.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN380ce6c2-3e29-4bdf-a600-f6990925a3074
359818nicotine 4 MG Oral LozengeSCD380ce6c2-3e29-4bdf-a600-f6990925a3074
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY380ce6c2-3e29-4bdf-a600-f6990925a3074
359818nicotine 4 MG TrocheSY380ce6c2-3e29-4bdf-a600-f6990925a3074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-087-81680160087813 BOTTLE, PLASTIC in 1 BOX (68016-087-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2019-04-302026-12-31NoNoCurrent