FDA.reportPublic FDA data

Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon

Product NDC
55741-001
11-digit product format
557410001
Labeler code
55741
Product ID
55741-001_bbc0d741-c935-487d-94ad-8e8eb77a70bc
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA079219
Marketing category
ANDA
Marketing start
2025-07-28
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
Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975, 2717264

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-001-10Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon10 in 1 BLISTER PACKGUM, CHEWING104
55741-001-15Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon10 in 1 BLISTER PACKGUM, CHEWING104
55741-001-15Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon15 in 1 CARTONGUM, CHEWING154
55741-001-80Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon10 in 1 BLISTER PACKGUM, CHEWING104
55741-001-80Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon8 in 1 CARTONGUM, CHEWING84

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717264Habitrol 4 MG Chewing GumPSN5c394758-1179-455a-a562-c8e954fb22584
311975nicotine polacrilex 4 MG Chewing GumPSN5c394758-1179-455a-a562-c8e954fb22584
2717264nicotine 4 MG Chewing Gum [Habitrol]SBD5c394758-1179-455a-a562-c8e954fb22584
311975nicotine 4 MG Chewing GumSCD5c394758-1179-455a-a562-c8e954fb22584
2717264Habitrol 4 MG Chewing GumSY5c394758-1179-455a-a562-c8e954fb22584
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY5c394758-1179-455a-a562-c8e954fb22584

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55741-001-105574100011010 GUM, CHEWING in 1 BLISTER PACK (55741-001-10) 2025-07-28NoNoHistorical
55741-001-155574100011515 BLISTER PACK in 1 CARTON (55741-001-15) / 10 GUM, CHEWING in 1 BLISTER PACK15 blister pack2025-07-28NoNoHistorical
55741-001-80557410001808 BLISTER PACK in 1 CARTON (55741-001-80) / 10 GUM, CHEWING in 1 BLISTER PACK8 blister pack2025-07-28NoNoHistorical