Habitrol
- Product NDC
- 43598-987
- 11-digit product format
- 435980987
- Labeler code
- 43598
- Product ID
- 43598-987_f9d24ed4-6477-a9bf-c3e2-ac408911a310
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex Lozenge 4 mg
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA212796
- Marketing category
- ANDA
- Marketing start
- 2021-05-21
- 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
- Brand name suffix
- 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, 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 |
|---|
| 43598-987 | HABITROL NICOTINE POLACRILEX LOZENGE MINT (NICOTINE POLACRILEX LOZENGE 2 MG) LOZENGE HABITROL NICOTINE POLACRILEX LOZENGE MINT (NICOTINE POLACRILEX LOZENGE 4 MG) LOZENGE [DR. REDDY'S LABORATORIES INC.] | 5 | Current NDC, Legacy NDC | 20240706_836bae74-076b-3c92-dee9-22b8519b529d.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 |
|---|
| 43598-987-13 | 43598098713 | 5 BOTTLE in 1 CARTON (43598-987-13) / 27 LOZENGE in 1 BOTTLE | 5 bottle | 2021-05-21 | 0000-00-00 | No | No | Current |
| 43598-987-24 | 43598098724 | 1 BOTTLE in 1 CARTON (43598-987-24) / 24 LOZENGE in 1 BOTTLE | 1 bottle | 2021-05-21 | 0000-00-00 | No | No | Current |
| 43598-987-27 | 43598098727 | 1 BOTTLE in 1 CARTON (43598-987-27) / 27 LOZENGE in 1 BOTTLE | 1 bottle | 2021-05-21 | 0000-00-00 | No | No | Current |
| 43598-987-72 | 43598098772 | 3 BOTTLE in 1 CARTON (43598-987-72) / 24 LOZENGE in 1 BOTTLE | 3 bottle | 2021-05-21 | 0000-00-00 | No | No | Current |