Over-the-counter drug · ANDA
Nicotine Polacrilex NDC 43598-484
Nicotine 2 mg/1 · Lozenge · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-484-10 | 43598048410 | 4 BOTTLE in 1 CARTON (43598-484-10) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-12 | 43598048412 | 5 BOTTLE in 1 CARTON (43598-484-12) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-13 | 43598048413 | 5 BOTTLE in 1 CARTON (43598-484-13) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-14 | 43598048414 | 6 BOTTLE in 1 CARTON (43598-484-14) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-16 | 43598048416 | 6 BOTTLE in 1 CARTON (43598-484-16) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-17 | 43598048417 | 7 BOTTLE in 1 CARTON (43598-484-17) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-18 | 43598048418 | 7 BOTTLE in 1 CARTON (43598-484-18) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-19 | 43598048419 | 8 BOTTLE in 1 CARTON (43598-484-19) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-22 | 43598048422 | 10 BOTTLE in 1 CARTON (43598-484-22) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-23 | 43598048423 | 8 BOTTLE in 1 CARTON (43598-484-23) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-24 | 43598048424 | 1 BOTTLE in 1 CARTON (43598-484-24) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-27 | 43598048427 | 1 BOTTLE in 1 CARTON (43598-484-27) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-29 | 43598048429 | 10 BOTTLE in 1 CARTON (43598-484-29) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-48 | 43598048448 | 2 BOTTLE in 1 CARTON (43598-484-48) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-54 | 43598048454 | 2 BOTTLE in 1 CARTON (43598-484-54) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-72 | 43598048472 | 3 BOTTLE in 1 CARTON (43598-484-72) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-73 | 43598048473 | 7 BOTTLE in 1 CARTON (43598-484-73) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-74 | 43598048474 | 7 BOTTLE in 1 CARTON (43598-484-74) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-81 | 43598048481 | 3 BOTTLE in 1 CARTON (43598-484-81) / 27 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 | |
| 43598-484-96 | 43598048496 | 4 BOTTLE in 1 CARTON (43598-484-96) / 24 LOZENGE in 1 BOTTLEMarketed from Sep 11, 2020 |
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)
- Nicotine Polacrilex
- Generic name (nonproprietary)
- nicotine polacrilex
- 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 212983
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 43598-484_39cca7cc-17e3-f297-e4f1-0a7e865b2f62SPL ID 39cca7cc-17e3-f297-e4f1-0a7e865b2f62SPL set ID 003b863c-06b0-715d-ccc2-b7da4deac621RxCUI 359817, 359818UNII 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
N443598048410followed by a unit qualifier and the quantityPackage 43598-0484-10. 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 212983
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 Original Flavornicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-982 |
| Habitrol Lozenge Original Flavornicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-983 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | LozengeOral | Dr. Reddy's Laboratories Inc. | 43598-485 |