Nicotine Polacrilex

Product NDC
69842-609
11-digit product format
698420609
Labeler code
69842
Product ID
69842-609_0ab21cfd-645a-4c3a-b497-f77099ed1c9f
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
CVS Pharmacy
Application
ANDA074707
Marketing category
ANDA
Marketing start
2014-01-01
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Polacrilex
Brand name suffix
original
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975, 314119

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
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-609-15Nicotine Polacrilexoriginal20 in 1 CARTONGUM, CHEWING2017
69842-609-15Nicotine Polacrilexoriginal1 in 1 BLISTER PACKGUM, CHEWING117
69842-609-50Nicotine Polacrilexoriginal50 in 1 CARTONGUM, CHEWING5017
69842-609-50Nicotine Polacrilexoriginal1 in 1 BLISTER PACKGUM, CHEWING117
69842-609-79Nicotine Polacrilexoriginal10 in 1 CARTONGUM, CHEWING1017
69842-609-79Nicotine Polacrilexoriginal1 in 1 BLISTER PACKGUM, CHEWING117
69842-609-98Nicotine Polacrilexoriginal170 in 1 CARTONGUM, CHEWING17017
69842-609-98Nicotine Polacrilexoriginal1 in 1 BLISTER PACKGUM, CHEWING117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-609-15EA - Each69842-609169df53f-1948-4977-bd1d-ccfa2ff8b4f712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-609NICOTINE POLACRILEX ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CVS PHARMACY]11Current NDC, Legacy NDC, 8 package rows20241006_62231539-ae9f-4665-ba59-bef047e93d8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN62231539-ae9f-4665-ba59-bef047e93d8a17
311975nicotine polacrilex 4 MG Chewing GumPSN62231539-ae9f-4665-ba59-bef047e93d8a17
314119nicotine 2 MG Chewing GumSCD62231539-ae9f-4665-ba59-bef047e93d8a17
311975nicotine 4 MG Chewing GumSCD62231539-ae9f-4665-ba59-bef047e93d8a17
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY62231539-ae9f-4665-ba59-bef047e93d8a17
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY62231539-ae9f-4665-ba59-bef047e93d8a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-609-156984206091520 BLISTER PACK in 1 CARTON (69842-609-15) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2014-01-010000-00-00NoNoCurrent
69842-609-506984206095050 BLISTER PACK in 1 CARTON (69842-609-50) / 1 GUM, CHEWING in 1 BLISTER PACK50 blister pack2014-01-010000-00-00NoNoCurrent
69842-609-796984206097910 BLISTER PACK in 1 CARTON (69842-609-79) / 1 GUM, CHEWING in 1 BLISTER PACK10 blister pack2014-01-010000-00-00NoNoCurrent
69842-609-9869842060998170 BLISTER PACK in 1 CARTON (69842-609-98) / 1 GUM, CHEWING in 1 BLISTER PACK170 blister pack2014-01-010000-00-00NoNoCurrent