signature care nicotine

Product NDC
21130-172
11-digit product format
211300172
Labeler code
21130
Product ID
21130-172_22010ed8-7fa6-402a-a314-523538183a55
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Safeway
Application
ANDA203690
Marketing category
ANDA
Marketing start
2018-10-29
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
signature care nicotine
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
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
21130-172-02signature care nicotine27 in 1 CONTAINERLOZENGE271
21130-172-02signature care nicotine3 in 1 CARTONLOZENGE31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-172SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]1Current NDC, Legacy NDC, 2 package rows20181110_22010ed8-7fa6-402a-a314-523538183a55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN22010ed8-7fa6-402a-a314-523538183a551
359817nicotine 2 MG Oral LozengeSCD22010ed8-7fa6-402a-a314-523538183a551
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY22010ed8-7fa6-402a-a314-523538183a551
359817nicotine 2 MG TrocheSY22010ed8-7fa6-402a-a314-523538183a551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-172-02211300172023 CONTAINER in 1 CARTON (21130-172-02) / 27 LOZENGE in 1 CONTAINER3 container2018-10-290000-00-00NoNoCurrent