Nicotine
- Product NDC
- 0363-0365
- 11-digit product format
- 003630365
- Labeler code
- 0363
- Product ID
- 0363-0365_3f364d1d-07d0-4b85-bda1-bc5edcac2652
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- ANDA091349
- Marketing category
- ANDA
- Marketing start
- 2013-03-22
- Marketing end
- 0000-00-00
- Substance
- NICOTINE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NICOTINE | ACTIVE INGREDIENT | 6M3C89ZY6R | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| NICOTINE | ACTIVE MOIETY | 6M3C89ZY6R | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| MALTITOL | INACTIVE INGREDIENT | D65DG142WK | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| POLACRILIN | INACTIVE INGREDIENT | RCZ785HI7S | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-0365 | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] | 9 | Legacy NDC | 20221020_9adf55d6-330b-4828-bab3-befad8c950ef.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0363-0365-06 | 00363036506 | 160 BLISTER PACK in 1 CARTON (0363-0365-06) > 1 GUM, CHEWING in 1 BLISTER PACK | 160 blister pack | 2013-06-07 | 0000-00-00 | No | No | Current |
| 0363-0365-76 | 00363036576 | 120 BLISTER PACK in 1 CARTON (0363-0365-76) > 1 GUM, CHEWING in 1 BLISTER PACK | 120 blister pack | 2014-04-10 | 0000-00-00 | No | No | Current |
| 0363-0365-78 | 00363036578 | 100 BLISTER PACK in 1 CARTON (0363-0365-78) > 1 GUM, CHEWING in 1 BLISTER PACK | 100 blister pack | 2013-06-07 | 0000-00-00 | No | No | Current |