Nicotine Mini

Product NDC
46122-715
11-digit product format
461220715
Labeler code
46122
Product ID
46122-715_57ac2e5a-6e8a-4a62-8d74-21e6a1c1ae8b
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application
ANDA207868
Marketing category
ANDA
Marketing start
2023-02-06
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Mini
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

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
46122-715-60Nicotine Mini20 in 1 BOTTLE, PLASTICLOZENGE203
46122-715-60Nicotine Mini1 in 1 BOXLOZENGE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-715-60EA - Each46122-71562da864a-b9a4-4f1d-b318-5e7834de377812023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-715NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]3Current NDC, Legacy NDC, 2 package rows20230321_ab184645-6fff-40cf-9859-4b8dec9098b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNab184645-6fff-40cf-9859-4b8dec9098b23
359817nicotine 2 MG Oral LozengeSCDab184645-6fff-40cf-9859-4b8dec9098b23
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYab184645-6fff-40cf-9859-4b8dec9098b23
359817nicotine 2 MG TrocheSYab184645-6fff-40cf-9859-4b8dec9098b23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-715-60461220715601 BOTTLE, PLASTIC in 1 BOX (46122-715-60) / 20 LOZENGE in 1 BOTTLE, PLASTIC2023-02-060000-00-00NoNoCurrent