signature care nicotine

Product NDC
21130-185
11-digit product format
211300185
Labeler code
21130
Product ID
21130-185_664c3faf-7cab-4bda-8987-07acb8e1142b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Safeway
Application
ANDA203690
Marketing category
ANDA
Marketing start
2018-10-22
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-185-02signature care nicotine27 in 1 CONTAINERLOZENGE271
21130-185-02signature care nicotine3 in 1 CARTONLOZENGE31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-185SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]1Current NDC, Legacy NDC, 2 package rows20181110_664c3faf-7cab-4bda-8987-07acb8e1142b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN664c3faf-7cab-4bda-8987-07acb8e1142b1
359818nicotine 4 MG Oral LozengeSCD664c3faf-7cab-4bda-8987-07acb8e1142b1
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY664c3faf-7cab-4bda-8987-07acb8e1142b1
359818nicotine 4 MG TrocheSY664c3faf-7cab-4bda-8987-07acb8e1142b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-185-02211300185023 CONTAINER in 1 CARTON (21130-185-02) / 27 LOZENGE in 1 CONTAINER3 container2018-10-220000-00-00NoNoCurrent