NDC 11822-3313

Nicotine Polacrilex

Nicotine Polacrilex

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

Product ID11822-3313_3728fb8b-e202-4340-8f57-678efabbd910
NDC11822-3313
Product TypeHuman Otc Drug
Proprietary NameNicotine Polacrilex
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationBUCCAL
Marketing Start Date2020-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA204794
Labeler NameRite Aid Corporation
Substance NameNICOTINE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 11822-3313-6

100 BLISTER PACK in 1 CARTON (11822-3313-6) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2020-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11822-3313-9 [11822331309]

Nicotine Polacrilex GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA204794
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-31

NDC 11822-3313-6 [11822331306]

Nicotine Polacrilex GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA204794
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-31

NDC 11822-3313-8 [11822331308]

Nicotine Polacrilex GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA204794
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NICOTINE2 mg/1

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

NDCBrand NameGeneric Name
68016-293Nicotine PolacrilexNicotine Polacrilex
68016-292Nicotine PolacrilexNicotine Polacrilex
0536-3405Nicotine PolacrilexNicotine Polacrilex
0536-3404Nicotine PolacrilexNicotine Polacrilex
11673-229NICOTINE POLACRILEXNICOTINE POLACRILEX
30142-170nicotine polacrilexnicotine polacrilex
45802-873Nicotine PolacrilexNicotine Polacrilex
45802-344Nicotine PolacrilexNicotine Polacrilex
45802-089Nicotine PolacrilexNicotine Polacrilex
45802-001Nicotine PolacrilexNicotine Polacrilex
45802-206Nicotine PolacrilexNicotine Polacrilex
45802-957Nicotine PolacrilexNicotine Polacrilex
49035-613Nicotine PolacrilexNicotine Polacrilex
50090-1152Nicotine PolacrilexNicotine Polacrilex
50090-1154Nicotine PolacrilexNicotine Polacrilex
55301-428Nicotine PolacrilexNicotine Polacrilex
55301-504Nicotine PolacrilexNicotine Polacrilex
55301-503Nicotine PolacrilexNicotine Polacrilex
55301-429Nicotine PolacrilexNicotine Polacrilex
59779-087nicotine polacrilexnicotine polacrilex
59779-918Nicotine PolacrilexNicotine Polacrilex
0363-0613Nicotine PolacrilexNicotine Polacrilex
63868-167Nicotine PolacrilexNicotine Polacrilex
63868-168Nicotine PolacrilexNicotine Polacrilex
37808-948nicotine polacrilexnicotine polacrilex
11822-2331Nicotine PolacrilexNicotine Polacrilex
11822-3326Nicotine PolacrilexNicotine Polacrilex
11822-3314Nicotine PolacrilexNicotine Polacrilex
11822-3313Nicotine PolacrilexNicotine Polacrilex
11822-2128Nicotine PolacrilexNicotine Polacrilex
11822-3325Nicotine PolacrilexNicotine Polacrilex
43598-486Nicotine PolacrilexNicotine Polacrilex
0113-0704basic care nicotineNicotine polacrilex
0113-0713basic care nicotineNicotine Polacrilex
0113-0749basic care nicotineNicotine Polacrilex
0113-0761basic care nicotineNicotine Polacrilex
0113-7007basic care nicotineNicotine Polacrilex
0113-7008basic care nicotinenicotine polacrilex
0113-7029basic care nicotineNicotine Polacrilex
0113-0029Good Sense NicotineNicotine Polacrilex
0113-0053Good Sense NicotineNicotine Polacrilex
0113-0170Good Sense NicotineNicotine Polacrilex
0113-0206good sense nicotineNicotine Polacrilex
0113-0344Good Sense NicotineNicotine Polacrilex
0113-0422Good Sense NicotineNicotine Polacrilex
0113-0456Good Sense NicotineNicotine Polacrilex
0113-0532Good Sense NicotineNicotine Polacrilex
0113-0734Good Sense NicotineNicotine Polacrilex
0113-0854Good Sense NicotineNicotine polacrilex
0113-0873good sense nicotineNicotine Polacrilex

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.