Nicotine COATED ice mint

Product NDC
68196-014
11-digit product format
681960014
Labeler code
68196
Product ID
68196-014_716673d9-891e-46af-8226-818bbdf5e439
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Sam's West, Inc.
Application
ANDA204833
Marketing category
ANDA
Marketing start
2017-10-16
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 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-014-012023-01-30C16284748780-1f386c649-ccbe-0266-e053-dadaa90a7c1aNicotine Gum Ice Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-014-01Nicotine COATED ice mint231 in 1 CARTONGUM, CHEWING2318
68196-014-01Nicotine COATED ice mint33 in 1 BLISTER PACKGUM, CHEWING338

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-014NICOTINE COATED ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST, INC.]8Legacy NDC, 2 package rows20210714_b11fde82-ea84-43b3-a0df-255d811259b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNb11fde82-ea84-43b3-a0df-255d811259b78
311975nicotine polacrilex 4 MG Chewing GumPSNb11fde82-ea84-43b3-a0df-255d811259b78
314119nicotine 2 MG Chewing GumSCDb11fde82-ea84-43b3-a0df-255d811259b78
311975nicotine 4 MG Chewing GumSCDb11fde82-ea84-43b3-a0df-255d811259b78
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYb11fde82-ea84-43b3-a0df-255d811259b78
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYb11fde82-ea84-43b3-a0df-255d811259b78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-014-0168196001401231 BLISTER PACK in 1 CARTON (68196-014-01) > 33 GUM, CHEWING in 1 BLISTER PACK231 blister pack2017-10-160000-00-00NoNoCurrent