Over-the-counter drug · ANDA
Nicotine Polacrilex MINT (Nicotine polacrilex) NDC 0363-1421
Nicotine 4 mg/1 · Gum, Chewing · Buccal · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1421-98 | 00363142198 | 170 BLISTER PACK in 1 CARTON (0363-1421-98) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 |
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)
- Nicotine Polacrilex MINTSuffix: MINT
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- WalgreensNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076568
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-1421_e26b02b7-365c-42f2-ad8a-4fac67909cacSPL ID e26b02b7-365c-42f2-ad8a-4fac67909cacSPL set ID 53c5ae28-5638-4217-9080-2bceba9a8885RxCUI 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400363142198followed by a unit qualifier and the quantityPackage 00363-1421-98. 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 0363-1421
- What is NDC 0363-1421?
- 0363-1421 is the product NDC for Nicotine Polacrilex MINT (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Walgreens. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine Polacrilex MINT (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Walgreens, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nicotine Polacrilex MINT?
- 1 other product NDC are listed under this name. See all Nicotine Polacrilex MINT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Polacrilex MINT products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotine Polacrilex MINTnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Walgreens | 0363-1420 | 00363-1420-98 |
Other NDCs under ANDA 076568
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 4 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-1372 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-720 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-725 |