Over-the-counter drug · ANDA
Habitrol Nicotine Polacrilex 2 mg Coated Cinnamon (Nicotine polacrilex) NDC 55741-004
Nicotine 2 mg/1 · Gum, Chewing · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55741-004-10 | 5574100041055741000410 | 10 GUM, CHEWING in 1 BLISTER PACK (55741-004-10)Marketed from Jul 28, 2025 | |
| 55741-004-15 | 5574100041555741000415 | 15 BLISTER PACK in 1 CARTON (55741-004-15) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 28, 2025 | |
| 55741-004-80 | 5574100048055741000480 | 8 BLISTER PACK in 1 CARTON (55741-004-80) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 28, 2025 |
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 2 mg Coated Cinnamon
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories Inc.NDC labeler code 55741
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079216
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 55741-004_7e00f967-584e-45d0-8d0e-759fe85ff0b4SPL ID 7e00f967-584e-45d0-8d0e-759fe85ff0b4SPL set ID 6874a9f1-d180-4073-8226-df6e21bcf0b7RxCUI 314119, 2717557UNII 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
N455741000410followed by a unit qualifier and the quantityPackage 55741-0004-10. 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.
About NDC 55741-004
- What is NDC 55741-004?
- 55741-004 is the product NDC for Habitrol Nicotine Polacrilex 2 mg Coated Cinnamon, Nicotine 2 mg/1 gum, chewing, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Habitrol Nicotine Polacrilex 2 mg Coated Cinnamon (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Dr. Reddy's Laboratories Inc., NDC labeler code 55741. 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 Nicotine Polacrilex 2 mg Coated Cinnamon?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 079216
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 |
|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3404 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | H E B | 37808-820 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-9240 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Rite Aid Corporation | 11822-2331 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-924 |
| Nicotine Polacrilex coated cinnamonnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-026 |