Nicotine

Product NDC: 0363-9780
11-digit product format: 003639780
Labeler code: 0363
Product ID: 0363-9780_a2d4089f-57bf-4a64-8749-fd577c74f82d
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Walgreens
Application: ANDA210711
Marketing category: ANDA
Marketing start: 2021-01-01
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	2 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6M3C89ZY6R
Rxcui	359817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-9780-27	Nicotine	27 in 1 BOTTLE, PLASTIC	LOZENGE	27		5
0363-9780-81	Nicotine	27 in 1 BOTTLE, PLASTIC	LOZENGE	27		5
0363-9780-81	Nicotine	3 in 1 BOX	LOZENGE	3		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9780	NICOTINE (NICOTINE POLACRILEX) LOZENGE [WALGREENS]	5	Current NDC, Legacy NDC, 3 package rows	20240223_446c857f-2380-4019-9a82-9fb9ee060d08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
359817	nicotine 2 MG Oral Lozenge	PSN	446c857f-2380-4019-9a82-9fb9ee060d08	5
359817	nicotine 2 MG Oral Lozenge	SCD	446c857f-2380-4019-9a82-9fb9ee060d08	5
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	446c857f-2380-4019-9a82-9fb9ee060d08	5
359817	nicotine 2 MG Troche	SY	446c857f-2380-4019-9a82-9fb9ee060d08	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-9780-27	00363978027	27 LOZENGE in 1 BOTTLE, PLASTIC (0363-9780-27)	27 lozenge	2021-01-01		No	No	Current
0363-9780-81	00363978081	3 BOTTLE, PLASTIC in 1 BOX (0363-9780-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC		2021-01-01	0000-00-00	No	No	Current