NDC 36800-532

Topcare Nicotine

Nicotine Polacrilex

Topcare Nicotine 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: 36800-532_28e82010-9a93-4cde-a733-aec52011ecd2
• NDC: 36800-532
• Product Type: Human Otc Drug
• Proprietary Name: Topcare Nicotine
• Generic Name: Nicotine Polacrilex
• Dosage Form: Gum, Chewing
• Route of Administration: ORAL
• Marketing Start Date: 2006-10-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076779
• Labeler Name: Topco Associates LLC
• Substance Name: NICOTINE
• Active Ingredient Strength: 4 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 36800-532-60

20 BLISTER PACK in 1 CARTON (36800-532-60) > 1 GUM, CHEWING in 1 BLISTER PACK

• Marketing Start Date: 2013-01-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-532-60 [36800053260]

Topcare Nicotine GUM, CHEWING

• Marketing Category: ANDA
• Application Number: ANDA076779
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-23

NDC 36800-532-76 [36800053276]

Topcare Nicotine GUM, CHEWING

• Marketing Category: ANDA
• Application Number: ANDA076779
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-08-25

NDC 36800-532-78 [36800053278]

Topcare Nicotine GUM, CHEWING

• Marketing Category: ANDA
• Application Number: ANDA076779
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-30

Drug Details

Active Ingredients

Ingredient	Strength
NICOTINE	4 mg/1

OpenFDA Data

• SPL SET ID: fa916f6b-0582-4e2a-bbed-6c47778c5d03
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • 6M3C89ZY6R
• RxNorm Concept Unique ID - RxCUI:
  • 311975

Medicade Reported Pricing

36800053278 NICOTINE 4 MG CHEWING GUM

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
36800-170	Topcare Nicotine	Topcare Nicotine
36800-456	Topcare Nicotine	Topcare Nicotine
36800-352	Topcare nicotine	Topcare nicotine
36800-539	Topcare Nicotine	Topcare Nicotine
36800-532	Topcare Nicotine	Topcare Nicotine
36800-029	TopCare Nicotine	TopCare Nicotine
36800-206	Topcare Nicotine	Topcare Nicotine
36800-957	Topcare Nicotine	Topcare Nicotine
36800-873	Topcare Nicotine	Topcare Nicotine
36800-734	Topcare Nicotine	Topcare Nicotine
36800-650	Topcare Nicotine	Topcare Nicotine
36800-269	topcare nicotine	topcare nicotine
36800-967	topcare nicotine	topcare nicotine
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