Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint
- Product NDC
- 75907-302
- 11-digit product format
- 759070302
- Labeler code
- 75907
- Product ID
- 75907-302_77318a2c-3e74-42e2-a76f-c11a7f2ca781
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA078699
- Marketing category
- ANDA
- Marketing start
- 2025-06-12
- Substance
- NICOTINE
- Active strength
- 2 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 Nicotine Polacrilex Gum 2 mg Coated Mint
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 314119, 2717557 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75907-302-10 | Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint | 10 in 1 BLISTER PACK | GUM, CHEWING | 10 | | 9 |
| 75907-302-15 | Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint | 10 in 1 BLISTER PACK | GUM, CHEWING | 10 | | 9 |
| 75907-302-15 | Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint | 15 in 1 CARTON | GUM, CHEWING | 15 | | 9 |
| 75907-302-80 | Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint | 10 in 1 BLISTER PACK | GUM, CHEWING | 10 | | 9 |
| 75907-302-80 | Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint | 8 in 1 CARTON | GUM, CHEWING | 8 | | 9 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 75907-302-10 | 75907030210 | 10 GUM, CHEWING in 1 BLISTER PACK (75907-302-10) | | 2025-06-12 | No | No | Current |
| 75907-302-15 | 75907030215 | 15 BLISTER PACK in 1 CARTON (75907-302-15) / 10 GUM, CHEWING in 1 BLISTER PACK | 15 blister pack | 2025-06-12 | No | No | Current |
| 75907-302-80 | 75907030280 | 8 BLISTER PACK in 1 CARTON (75907-302-80) / 10 GUM, CHEWING in 1 BLISTER PACK | 8 blister pack | 2025-06-12 | No | No | Current |