NDC 68196-011

Nicotine

Nicotine Polacrilex

Nicotine is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Sam's West, Inc.. The primary component is Nicotine.

• Product ID: 68196-011_209475e6-f90a-4408-9079-900c02373709
• NDC: 68196-011
• Product Type: Human Otc Drug
• Proprietary Name: Nicotine
• Generic Name: Nicotine Polacrilex
• Dosage Form: Gum, Chewing
• Route of Administration: ORAL
• Marketing Start Date: 2017-10-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074707
• Labeler Name: Sam's West, Inc.
• Substance Name: NICOTINE
• Active Ingredient Strength: 4 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68196-011-02

396 BLISTER PACK in 1 CARTON (68196-011-02) > 33 GUM, CHEWING in 1 BLISTER PACK

• Marketing Start Date: 2017-10-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68196-011-02 [68196001102]

Nicotine GUM, CHEWING

• Marketing Category: ANDA
• Application Number: ANDA074707
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-10-16

Drug Details

Active Ingredients

Ingredient	Strength
NICOTINE	4 mg/1

OpenFDA Data

• SPL SET ID: 809f691e-8886-4e59-bcd9-0d0dcc435375
• Manufacturer:
  • Sam's West, Inc.
• UNII:
  • 6M3C89ZY6R
• RxNorm Concept Unique ID - RxCUI:
  • 311975
  • 314119

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

NDC	Brand Name	Generic Name
68196-010	Nicotine	Nicotine
68196-011	Nicotine	Nicotine
0536-5895	Nicotine	Nicotine
0536-5894	Nicotine	Nicotine
0536-5896	Nicotine	Nicotine
69842-433	Nicotine	Nicotine
70677-0031	Nicotine	Nicotine
70677-0030	Nicotine	Nicotine
70677-0032	Nicotine	Nicotine
11822-0124	nicotine	nicotine
11822-0699	Nicotine	Nicotine
11822-0873	Nicotine	Nicotine
11822-0170	nicotine	nicotine
11822-0854	Nicotine	Nicotine
11822-0309	nicotine	nicotine
11822-0344	Nicotine	Nicotine
11822-0734	Nicotine	Nicotine
11822-0009	nicotine	nicotine
11822-0029	Nicotine	Nicotine
11822-0059	Nicotine	Nicotine
11822-0352	nicotine	nicotine
11822-0456	Nicotine	Nicotine
30142-124	Nicotine	Nicotine
30142-190	Nicotine	Nicotine
30142-208	Nicotine	Nicotine
30142-873	Nicotine	Nicotine
30142-309	Nicotine	Nicotine
30142-344	Nicotine	Nicotine
30142-749	nicotine	nicotine
30142-957	Nicotine	Nicotine
30142-854	Nicotine	Nicotine
30142-532	Nicotine	Nicotine
30142-029	nicotine	nicotine
30142-352	Nicotine	Nicotine
30142-456	Nicotine	Nicotine
37012-309	Nicotine	Nicotine
37808-349	Nicotine	Nicotine
37808-617	nicotine	nicotine
37012-012	Nicotine	Nicotine
37808-707	Nicotine	Nicotine
41250-029	nicotine	nicotine
41250-190	nicotine	nicotine
41250-532	Nicotine	Nicotine
37808-900	Nicotine	Nicotine
41250-734	Nicotine	Nicotine
41250-344	nicotine	nicotine
41250-957	Nicotine	Nicotine
41250-352	Nicotine	Nicotine
41250-510	Nicotine	Nicotine
41250-442	Nicotine	Nicotine