Habitrol Lozenge
- Product NDC
- 43598-983
- 11-digit product format
- 435980983
- Labeler code
- 43598
- Product ID
- 43598-983_71e4d8bd-c716-3f2d-2ee7-b13406a53939
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA212983
- Marketing category
- ANDA
- Marketing start
- 2022-04-01
- 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
- Habitrol Lozenge
- Brand name suffix
- Original Flavor
- 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, 2548896, 2548898 |
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 |
|---|
| 43598-983 | HABITROL LOZENGE ORIGINAL FLAVOR (NICOTINE POLACRILEX) LOZENGE [DR. REDDY'S LABORATORIES INC.] | 5 | Current NDC, Legacy NDC | 20240706_87714b79-05b3-f3c2-6505-5923e4f48871.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 |
|---|
| 43598-983-13 | 43598098313 | 5 BOTTLE in 1 CARTON (43598-983-13) / 27 LOZENGE in 1 BOTTLE | 5 bottle | 2022-04-01 | 0000-00-00 | No | No | Current |
| 43598-983-27 | 43598098327 | 1 BOTTLE in 1 CARTON (43598-983-27) / 27 LOZENGE in 1 BOTTLE | 1 bottle | 2022-04-01 | 0000-00-00 | No | No | Current |