Nicotine Polacrilex
- Product NDC
- 72484-429
- 11-digit product format
- 724840429
- Labeler code
- 72484
- Product ID
- 72484-429_956fb87b-f80a-6372-e053-2a95a90ac9ae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- Roman Health Ventures Inc.
- Application
- ANDA078697
- Marketing category
- ANDA
- Marketing start
- 2018-10-08
- Marketing end
- 0000-00-00
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72484-429-16 | Nicotine Polacrilexcoated mint | 160 in 1 CARTON | GUM, CHEWING | 160 | | 2 |
| 72484-429-16 | Nicotine Polacrilexcoated mint | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72484-429 | NICOTINE POLACRILEX COATED MINT (NICOTINE POLACRILEX) GUM, CHEWING [ROMAN HEALTH VENTURES INC.] | 2 | Legacy NDC, 2 package rows | 20191024_d60f90a5-10ea-442b-9ec5-2f2a69ec6441.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72484-429-16 | 72484042916 | 160 BLISTER PACK in 1 CARTON (72484-429-16) > 1 GUM, CHEWING in 1 BLISTER PACK | 160 blister pack | 2018-10-08 | 0000-00-00 | No | No | Current |