signature care nicotine

Product NDC
21130-700
11-digit product format
211300700
Labeler code
21130
Product ID
21130-700_521da7c7-0dda-4f3a-9c0a-b4f2c17098ab
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Safeway
Application
ANDA077007
Marketing category
ANDA
Marketing start
2015-10-06
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-700-05signature care nicotine24 in 1 CONTAINERLOZENGE247
21130-700-05signature care nicotine3 in 1 CARTONLOZENGE37

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-700SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [SAFEWAY]7Current NDC, Legacy NDC, 2 package rows20221118_cb2624de-3908-4091-aea1-f0dc76abd633.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNcb2624de-3908-4091-aea1-f0dc76abd6337
359817nicotine 2 MG Oral LozengeSCDcb2624de-3908-4091-aea1-f0dc76abd6337
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYcb2624de-3908-4091-aea1-f0dc76abd6337
359817nicotine 2 MG TrocheSYcb2624de-3908-4091-aea1-f0dc76abd6337

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-700-05211300700053 CONTAINER in 1 CARTON (21130-700-05) / 24 LOZENGE in 1 CONTAINER3 container2015-10-060000-00-00NoNoCurrent