Nicotine

Product NDC
11822-0905
11-digit product format
118220905
Labeler code
11822
Product ID
11822-0905_a5b861e0-8aeb-4cbd-897f-011f99d04299
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA212056
Marketing category
ANDA
Marketing start
2020-08-01
Marketing end
2026-12-31
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine

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
11822-0905-4Nicotine24 in 1 BOTTLE, PLASTICLOZENGE246
11822-0905-4Nicotine3 in 1 BOXLOZENGE36
11822-0905-7Nicotine24 in 1 BOTTLE, PLASTICLOZENGE246
11822-0905-7Nicotine1 in 1 BOXLOZENGE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0905NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION]5Current NDC, Legacy NDC, 4 package rows20231102_9f77adad-4b67-48c8-9ad4-24bccdea3ae2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN9f77adad-4b67-48c8-9ad4-24bccdea3ae26
359818nicotine 4 MG Oral LozengeSCD9f77adad-4b67-48c8-9ad4-24bccdea3ae26
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY9f77adad-4b67-48c8-9ad4-24bccdea3ae26
359818nicotine 4 MG TrocheSY9f77adad-4b67-48c8-9ad4-24bccdea3ae26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-0905-4118220905043 BOTTLE, PLASTIC in 1 BOX (11822-0905-4) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-08-012026-12-31NoNoCurrent
11822-0905-7118220905071 BOTTLE, PLASTIC in 1 BOX (11822-0905-7) / 24 LOZENGE in 1 BOTTLE, PLASTIC2020-08-012026-12-31NoNoCurrent