signature care nicotine

Product NDC
21130-211
11-digit product format
211300211
Labeler code
21130
Product ID
21130-211_bdf1a198-bce7-4934-86e1-2e45ddd743c7
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Safeway
Application
ANDA077007
Marketing category
ANDA
Marketing start
2015-09-28
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
signature care 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
21130-211-05signature care nicotine3 in 1 CARTONLOZENGE33
21130-211-05signature care nicotine24 in 1 CONTAINERLOZENGE243

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-211SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]3Current NDC, Legacy NDC, 2 package rows20180919_420c0858-c0af-45d0-b048-5d6275530317.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN420c0858-c0af-45d0-b048-5d62755303173
359818nicotine 4 MG Oral LozengeSCD420c0858-c0af-45d0-b048-5d62755303173
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY420c0858-c0af-45d0-b048-5d62755303173
359818nicotine 4 MG TrocheSY420c0858-c0af-45d0-b048-5d62755303173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-211-05211300211053 CONTAINER in 1 CARTON (21130-211-05) / 24 LOZENGE in 1 CONTAINER3 container2015-09-280000-00-00NoNoCurrent