Nicotine Polacrilex Lozenge Mint
- Product NDC
- 63868-732
- 11-digit product format
- 638680732
- Labeler code
- 63868
- Product ID
- 63868-732_618550c1-391c-c6a7-c2b5-19d3bfc78419
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex Lozenge 4 mg
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association INC
- Application
- ANDA212796
- Marketing category
- ANDA
- Marketing start
- 2021-04-01
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex Lozenge Mint
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 359817, 359818 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-732 | NICOTINE POLACRILEX LOZENGE MINT (NICOTINE POLACRILEX LOZENGE 2 MG) LOZENGE NICOTINE POLACRILEX LOZENGE MINT (NICOTINE POLACRILEX LOZENGE 4 MG) LOZENGE [CHAIN DRUG MARKETING ASSOCIATION INC] | 4 | Current NDC, Legacy NDC | 20240730_e0234492-d92d-ee93-493f-1099d4544722.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 |
|---|
| 63868-732-24 | 63868073224 | 1 BOTTLE in 1 CARTON (63868-732-24) / 24 LOZENGE in 1 BOTTLE | 1 bottle | 2021-04-01 | 0000-00-00 | No | No | Current |
| 63868-732-72 | 63868073272 | 3 BOTTLE in 1 CARTON (63868-732-72) / 24 LOZENGE in 1 BOTTLE | 3 bottle | 2021-04-01 | 0000-00-00 | No | No | Current |