Over-the-counter drug · ANDA
Habitrol Nicotine Polacrilex Lozenge Mint NDC 43598-986
nicotine polacrilex lozenge 2 mg · Nicotine 2 mg/1 · Lozenge · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-986-13 | 43598098613 | 5 BOTTLE in 1 CARTON (43598-986-13) / 27 LOZENGE in 1 BOTTLEMarketed from May 21, 2021 | |
| 43598-986-24 | 43598098624 | 1 BOTTLE in 1 CARTON (43598-986-24) / 24 LOZENGE in 1 BOTTLEMarketed from May 21, 2021 | |
| 43598-986-27 | 43598098627 | 1 BOTTLE in 1 CARTON (43598-986-27) / 27 LOZENGE in 1 BOTTLEMarketed from May 21, 2021 | |
| 43598-986-72 | 43598098672 | 3 BOTTLE in 1 CARTON (43598-986-72) / 24 LOZENGE in 1 BOTTLEMarketed from May 21, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Habitrol Nicotine Polacrilex Lozenge MintSuffix: Nicotine Polacrilex Lozenge Mint
- Generic name (nonproprietary)
- nicotine polacrilex lozenge 2 mg
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212796
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 43598-986_2937531d-c1b4-4c9b-4310-a18870ac1b78SPL ID 2937531d-c1b4-4c9b-4310-a18870ac1b78SPL set ID 836bae74-076b-3c92-dee9-22b8519b529dRxCUI 359817, 359818, 2548896, 2548898UNII 6M3C89ZY6R
- Pharmacologic class
- Cholinergic Nicotinic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N443598098613followed by a unit qualifier and the quantityPackage 43598-0986-13. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212796
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Habitrol Nicotine Polacrilex Lozenge Mintnicotine polacrilex lozenge 4 mg | Nicotine 4 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-987 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-487 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-486 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | LozengeOral | Bryant Ranch Prepack | 72162-2266 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | LozengeOral | Bryant Ranch Prepack | 72162-2267 |