Nicotine

Product NDC
37808-707
11-digit product format
378080707
Labeler code
37808
Product ID
37808-707_6b80e147-61ca-4cd6-bd3f-2500ae0ad31a
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
LOZENGE
Route
ORAL
Labeler
H E B
Application
ANDA203690
Marketing category
ANDA
Marketing start
2018-10-01
Substance
NICOTINE
Active strength
4 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
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
37808-707-01Nicotine27 in 1 CONTAINERLOZENGE273
37808-707-01Nicotine1 in 1 CARTONLOZENGE13
37808-707-03Nicotine27 in 1 CONTAINERLOZENGE273
37808-707-03Nicotine4 in 1 CARTONLOZENGE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-707NICOTINE LOZENGE [H E B]2Current NDC, Legacy NDC, 4 package rows20181017_85e3a322-e1a2-4f8e-a616-b279ad1bcefe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN85e3a322-e1a2-4f8e-a616-b279ad1bcefe3
359818nicotine 4 MG Oral LozengeSCD85e3a322-e1a2-4f8e-a616-b279ad1bcefe3
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY85e3a322-e1a2-4f8e-a616-b279ad1bcefe3
359818nicotine 4 MG TrocheSY85e3a322-e1a2-4f8e-a616-b279ad1bcefe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-707-01378080707011 CONTAINER in 1 CARTON (37808-707-01) / 27 LOZENGE in 1 CONTAINER1 container2018-10-012026-09-30NoNoCurrent
37808-707-03378080707034 CONTAINER in 1 CARTON (37808-707-03) / 27 LOZENGE in 1 CONTAINER4 container2018-10-010000-00-00NoNoCurrent