Kirkland Signature Nicotine

Product NDC
63981-190
11-digit product format
639810190
Labeler code
63981
Product ID
63981-190_b864361c-f31a-4bdf-b033-828f7f204f1e
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
LOZENGE
Route
ORAL
Labeler
Costco Wholesale Company
Application
ANDA090711
Marketing category
ANDA
Marketing start
2020-05-08
Substance
NICOTINE
Active strength
4 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
Kirkland Signature Nicotine
Listing expiration
2026-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
63981-190-37Kirkland Signature Nicotine27 in 1 CONTAINERLOZENGE273
63981-190-37Kirkland Signature Nicotine10 in 1 PACKAGELOZENGE103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-190-37EA - Each63981-1900ef6f217-6c8c-4c81-b60a-8f6f22e9648012020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-190KIRKLAND SIGNATURE NICOTINE (NICOTINE) LOZENGE [COSTCO WHOLESALE COMPANY]3Current NDC, Legacy NDC, 2 package rows20230609_0888a974-a8ba-4cb3-996f-c8abfcb90a6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN0888a974-a8ba-4cb3-996f-c8abfcb90a6f3
359818nicotine 4 MG Oral LozengeSCD0888a974-a8ba-4cb3-996f-c8abfcb90a6f3
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY0888a974-a8ba-4cb3-996f-c8abfcb90a6f3
359818nicotine 4 MG TrocheSY0888a974-a8ba-4cb3-996f-c8abfcb90a6f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-190-376398101903710 CONTAINER in 1 PACKAGE (63981-190-37) / 27 LOZENGE in 1 CONTAINER10 container2020-05-080000-00-00NoNoCurrent