FDA.reportPublic FDA data

Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint

Product NDC
75907-303
11-digit product format
759070303
Labeler code
75907
Product ID
75907-303_6dec3f9c-5e70-4992-aae4-822d470312a5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA078697
Marketing category
ANDA
Marketing start
2025-06-12
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 Gum 4 mg Coated Mint
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-303-10Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint10 in 1 BLISTER PACKGUM, CHEWING1010
75907-303-15Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint10 in 1 BLISTER PACKGUM, CHEWING1010
75907-303-15Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint15 in 1 CARTONGUM, CHEWING1510
75907-303-80Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint8 in 1 CARTONGUM, CHEWING810
75907-303-80Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint10 in 1 BLISTER PACKGUM, CHEWING1010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717264Habitrol 4 MG Chewing GumPSNed5722d7-746b-468e-89b5-506055d12bbd10
311975nicotine polacrilex 4 MG Chewing GumPSNed5722d7-746b-468e-89b5-506055d12bbd10
2717264nicotine 4 MG Chewing Gum [Habitrol]SBDed5722d7-746b-468e-89b5-506055d12bbd10
311975nicotine 4 MG Chewing GumSCDed5722d7-746b-468e-89b5-506055d12bbd10
2717264Habitrol 4 MG Chewing GumSYed5722d7-746b-468e-89b5-506055d12bbd10
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYed5722d7-746b-468e-89b5-506055d12bbd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-303-107590703031010 GUM, CHEWING in 1 BLISTER PACK (75907-303-10) 2025-06-12NoNoCurrent
75907-303-157590703031515 BLISTER PACK in 1 CARTON (75907-303-15) / 10 GUM, CHEWING in 1 BLISTER PACK15 blister pack2025-06-12NoNoCurrent
75907-303-80759070303808 BLISTER PACK in 1 CARTON (75907-303-80) / 10 GUM, CHEWING in 1 BLISTER PACK8 blister pack2025-06-12NoNoCurrent