Over-the-counter drug · NDA
Nicorette Spearmint Burst (Nicotine polacrilex) NDC 0135-0533
Nicotine 4 mg/1 · Gum, Chewing · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0533-02 | 0013505330200135053302 | 10 BLISTER PACK in 1 CARTON (0135-0533-02) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Sep 13, 2017 | |
| 0135-0533-12 | 0013505331200135053312 | 2 CARTON in 1 PACKAGE (0135-0533-12) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Mar 1, 2018 | |
| 0135-0533-13 | 0013505331300135053313 | 12 BLISTER PACK in 1 CARTON (0135-0533-13) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Sep 1, 2018 | |
| 0135-0533-14 | 0013505331400135053314 | 18 BLISTER PACK in 1 CARTON (0135-0533-14) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 3, 2018 |
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 Spearmint BurstSuffix: Spearmint Burst
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0135
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020066
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0135-0533_1f929250-cbfa-d6eb-e063-6394a90a7281SPL ID 1f929250-cbfa-d6eb-e063-6394a90a7281SPL set ID 673fd19f-69b3-4f73-b9b4-18b5f4cbf69cRxCUI 105071, 209326, 311975, 314119UNII 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
N400135053302followed by a unit qualifier and the quantityPackage 00135-0533-02. 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 0135-0533
- What is NDC 0135-0533?
- 0135-0533 is the product NDC for Nicorette Spearmint Burst (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Haleon US Holdings LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicorette Spearmint Burst (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 Spearmint Burst?
- 2 other product NDCs are listed under this name. See all Nicorette Spearmint Burst NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicorette Spearmint Burst products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicorette Spearmint Burstnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0355 | 00135-0355-03 |
| Nicorette Spearmint Burstnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0532 | 00135-0532-0200135-0532-0300135-0532-12+2 more |
Other NDCs under NDA 020066
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 |
|---|---|---|---|---|
| Nicorette 4mg Cinnamon Surgenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Lil' Drug Store products, Inc. | 66715-8123 |
| Nicorette 4mg Fruit Chill Gum, Lil Drug Storenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Lil' Drug Store Products, Inc. | 66715-8124 |
| Nicorette 4mg White Ice Mint Gum, Lil Drug Storenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Lil' Drug Store Products, Inc. | 66715-8125 |
| Nicorette Cinnamon Surgenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0467 |
| Nicorette Fruit Chillnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0242 |
| Nicorette Fruit Chill nicotine polacrilexnicotine | Nicotine 4 mg/1 | Gum, ChewingOral | Lil' Drug Store Products, Inc. | 29485-5270 |
| Nicorette Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0230 |
| Nicorette Originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0158 |
| Nicorette Spearmint Burstnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0355 |
| Nicorette White Ice Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0475 |
| Nicorette White Mint nicotine polacrilexnicotine | Nicotine 4 mg/1 | Gum, ChewingOral | Lil' Drug Store Products, Inc. | 29485-5271 |