Over-the-counter drug · NDA
Nicorette (Nicotine polacrilex) NDC 0135-0626
Nicotine 4 mg/1 · Lozenge · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0626-01 | 00135062601 | 1 CONTAINER in 1 CARTON (0135-0626-01) / 20 LOZENGE in 1 CONTAINERMarketed from Apr 11, 2019 | |
| 0135-0626-02 | 00135062602 | 4 CONTAINER in 1 CARTON (0135-0626-02) / 20 LOZENGE in 1 CONTAINERMarketed from Apr 11, 2019 | |
| 0135-0626-03 | 00135062603 | 6 CONTAINER in 1 CARTON (0135-0626-03) / 20 LOZENGE in 1 CONTAINERMarketed from Oct 23, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Nicorette
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0135
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021330
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0135-0626_36c1b8d5-e876-dc22-e063-6294a90aff3bSPL ID 36c1b8d5-e876-dc22-e063-6294a90aff3bSPL set ID f350e050-2173-43e0-8738-848382ce0700RxCUI 359817, 359818, 968849, 968851UNII 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
N400135062601followed by a unit qualifier and the quantityPackage 00135-0626-01. 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 0135-0626
- What is NDC 0135-0626?
- 0135-0626 is the product NDC for Nicorette (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicorette (Nicotine polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nicorette?
- 8 other product NDCs are listed under this name. See all Nicorette NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicorette products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0635 | 00135-0635-01 |
| Nicorettenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0636 | 00135-0636-01 |
| Nicorettenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-1500 | 00135-1500-0100135-1500-02 |
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-2800 | 00135-2800-0100135-2800-02 |
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0625 | 00135-0625-0100135-0625-0200135-0625-03 |
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0510 | 00135-0510-0100135-0510-0600135-0510-07 |
| Nicorettenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0511 | 00135-0511-0100135-0511-0600135-0511-07 |
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0508 | 00135-0508-0200135-0508-0300135-0508-04 |
Other NDCs under NDA 021330
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 |
|---|---|---|---|---|
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0510 |
| Nicorettenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0511 |
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0625 |