NDC 36800-863

Topcare Nicotine Gum

Nicotine Polacrilex

Topcare Nicotine Gum is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Nicotine.

• Product ID: 36800-863_162bf6ad-46eb-4944-b2b0-d0c0bd5b8ba9
• NDC: 36800-863
• Product Type: Human Otc Drug
• Proprietary Name: Topcare Nicotine Gum
• Generic Name: Nicotine Polacrilex
• Dosage Form: Gum, Chewing
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206394
• Labeler Name: Topco Associates LLC
• Substance Name: NICOTINE
• Active Ingredient Strength: 2 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 36800-863-78

100 BLISTER PACK in 1 CARTON (36800-863-78) > 1 GUM, CHEWING in 1 BLISTER PACK

• Marketing Start Date: 2017-02-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-863-78 [36800086378]

Topcare Nicotine Gum GUM, CHEWING

• Marketing Category: ANDA
• Application Number: ANDA206394
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-13

Drug Details

Active Ingredients

Ingredient	Strength
NICOTINE	2 mg/1

OpenFDA Data

• SPL SET ID: f0f79275-c27a-4d35-a79a-53b0905c3761
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • 6M3C89ZY6R
• RxNorm Concept Unique ID - RxCUI:
  • 314119
• UPC Code:
  • 0012345678905

NDC Crossover Matching brand name "Topcare Nicotine Gum" or generic name "Nicotine Polacrilex"

NDC	Brand Name	Generic Name
36800-863	Topcare Nicotine Gum	Topcare 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