nicotine

Product NDC
37808-617
11-digit product format
378080617
Labeler code
37808
Product ID
37808-617_97b9354e-771d-4155-9104-8f81b3fe69c3
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
H E B
Application
ANDA203690
Marketing category
ANDA
Marketing start
2018-11-08
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine
Listing expiration
2027-12-31

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
37808-617-09nicotine27 in 1 CONTAINERLOZENGE272
37808-617-10nicotine4 in 1 CARTONLOZENGE42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-617NICOTINE (NICOTINE POLACRILEX) LOZENGE [H E B]1Current NDC, Legacy NDC, 2 package rows20181116_b1a13942-1fad-40da-8664-f70574b950d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNb1a13942-1fad-40da-8664-f70574b950d72
359817nicotine 2 MG Oral LozengeSCDb1a13942-1fad-40da-8664-f70574b950d72
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYb1a13942-1fad-40da-8664-f70574b950d72
359817nicotine 2 MG TrocheSYb1a13942-1fad-40da-8664-f70574b950d72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-617-093780806170927 in 1 CONTAINERHistorical
37808-617-10378080617104 CONTAINER in 1 CARTON (37808-617-10) / 27 LOZENGE in 1 CONTAINER (37808-617-09) 4 container2018-11-080000-00-00NoNoCurrent