NDC 11822-0365

nicotine gum

Nicotine Polacrilex

nicotine gum is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Rite Aid Corporation. The primary component is Nicotine.

• Product ID: 11822-0365_3d2fec60-48a6-494f-a663-35a85661a1c1
• NDC: 11822-0365
• Product Type: Human Otc Drug
• Proprietary Name: nicotine gum
• Generic Name: Nicotine Polacrilex
• Dosage Form: Gum, Chewing
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091349
• Labeler Name: Rite Aid Corporation
• Substance Name: NICOTINE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 11822-0365-1

100 BLISTER PACK in 1 CARTON (11822-0365-1) > 1 GUM, CHEWING in 1 BLISTER PACK

• Marketing Start Date: 2016-07-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 11822-0365-3 [11822036503]

nicotine gum GUM, CHEWING

• Marketing Category: ANDA
• Application Number: ANDA091349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-10-25

NDC 11822-0365-1 [11822036501]

nicotine gum GUM, CHEWING

• Marketing Category: ANDA
• Application Number: ANDA091349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-07-30

NDC 11822-0365-2 [11822036502]

nicotine gum GUM, CHEWING

• Marketing Category: ANDA
• Application Number: ANDA091349
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-12

Drug Details

Active Ingredients

Ingredient	Strength
NICOTINE	2 mg/1

OpenFDA Data

• SPL SET ID: 3872c622-1a30-459c-b878-61648bb30627
• Manufacturer:
  • Rite Aid Corporation
• UNII:
  • 6M3C89ZY6R
• RxNorm Concept Unique ID - RxCUI:
  • 314119

NDC Crossover Matching brand name "nicotine gum" or generic name "Nicotine Polacrilex"

NDC	Brand Name	Generic Name
11822-0365	nicotine gum	nicotine gum
0113-0704	basic care nicotine	Nicotine polacrilex
0113-0713	basic care nicotine	Nicotine Polacrilex
0113-0749	basic care nicotine	Nicotine Polacrilex
0113-0761	basic care nicotine	Nicotine Polacrilex
0113-7007	basic care nicotine	Nicotine Polacrilex
0113-7008	basic care nicotine	nicotine polacrilex
0113-7029	basic care nicotine	Nicotine Polacrilex
0113-0029	Good Sense Nicotine	Nicotine Polacrilex
0113-0053	Good Sense Nicotine	Nicotine Polacrilex
0113-0170	Good Sense Nicotine	Nicotine Polacrilex
0113-0206	good sense nicotine	Nicotine Polacrilex
0113-0344	Good Sense Nicotine	Nicotine Polacrilex
0113-0422	Good Sense Nicotine	Nicotine Polacrilex
0113-0456	Good Sense Nicotine	Nicotine Polacrilex
0113-0532	Good Sense Nicotine	Nicotine Polacrilex
0113-0734	Good Sense Nicotine	Nicotine Polacrilex
0113-0854	Good Sense Nicotine	Nicotine polacrilex
0113-0873	good sense nicotine	Nicotine Polacrilex
0113-0957	Good Sense Nicotine	Nicotine Polacrilex
0113-1125	Good Sense Nicotine	Nicotine Polacrilex
0113-1190	good sense nicotine	Nicotine Polacrilex
0113-1352	good sense nicotine	Nicotine Polacrilex
0113-6000	Tru Relief Nicotine	Nicotine Polacrilex
0113-6001	Tru Relief Nicotine	Nicotine Polacrilex