Over-the-counter drug · ANDA
Habitrol Lozenge Cherry (Nicotine polacrilex) NDC 43598-985
Nicotine 4 mg/1 · Lozenge · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-985-13 | 4359809851343598098513 | 5 BOTTLE in 1 CARTON (43598-985-13) / 27 LOZENGE in 1 BOTTLEMarketed from Nov 30, 2021 | |
| 43598-985-72 | 4359809857243598098572 | 3 BOTTLE in 1 CARTON (43598-985-72) / 24 LOZENGE in 1 BOTTLEMarketed from Nov 30, 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 Lozenge CherrySuffix: Cherry
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories Inc.NDC labeler code 43598
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213233
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 43598-985_bfd76693-9b73-cc74-5d02-99afc0a505caSPL ID bfd76693-9b73-cc74-5d02-99afc0a505caSPL set ID 5a464242-7d63-141e-808e-c41676cf4b78RxCUI 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
N443598098513followed by a unit qualifier and the quantityPackage 43598-0985-13. 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.
About NDC 43598-985
- What is NDC 43598-985?
- 43598-985 is the product NDC for Habitrol Lozenge Cherry (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Habitrol Lozenge Cherry (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Habitrol Lozenge Cherry?
- 1 other product NDC are listed under this name. See all Habitrol Lozenge Cherry NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Habitrol Lozenge Cherry products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Habitrol Lozenge Cherrynicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-984 | 43598-0984-1343598-0984-72 |
Other NDCs under ANDA 213233
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 Lozenge Cherrynicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-984 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-488 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-489 |