Over-the-counter drug · ANDA
Nicotine (Nicotine polacrilex) NDC 0363-9250
Nicotine 2 mg/1 · Gum, Chewing · Buccal · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-9250-10 | 0036392501000363925010 | 100 BLISTER PACK in 1 CARTON (0363-9250-10) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 29, 2021 | |
| 0363-9250-16 | 0036392501600363925016 | 160 BLISTER PACK in 1 CARTON (0363-9250-16) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 29, 2021 | |
| 0363-9250-20 | 0036392502000363925020 | 20 BLISTER PACK in 1 CARTON (0363-9250-20) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 29, 2021 |
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
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 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 079044
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-9250_4c379eb0-3902-4c1a-a47e-464017fb482aSPL ID 4c379eb0-3902-4c1a-a47e-464017fb482aSPL set ID cce1153e-ad7b-4c8a-a4eb-5b08b4652688RxCUI 314119UNII 6M3C89ZY6RUPC 0311917032511
- 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
N400363925010followed by a unit qualifier and the quantityPackage 00363-9250-10. 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 0363-9250
- What is NDC 0363-9250?
- 0363-9250 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 2 mg/1 gum, chewing, listed with the FDA by Walgreens. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine (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?
- 197 other product NDCs are listed under this name. See all Nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-684 | 72288-0684-02 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-730 | 72288-0730-60 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-755 | 72288-0755-06 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-863 | 72288-0863-06 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Safeway | 21130-772 | 21130-0772-02 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-969 | 72288-0969-76 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-869 | 72288-0869-76 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Cardinal Health 107, LLC | 55154-6818 | 55154-6818-00 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-651 | 72288-0651-14 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-2511 | 00363-2511-27 |
Other NDCs under ANDA 079044
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 Nicotine Polacrilex Gum 2 mg Coated Fruitnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Dr. Reddy's Laboratories Inc. | 75907-301 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | P & L Development, LLC | 59726-592 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | AAFES/Your Military Exchanges | 55301-503 |
| Nicotine Polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-925 |
| Nicotine Polacrilex Coated Fruitnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-503 |
| Nicotine Polacrilex coated fruitnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-024 |
| Nicotine Polacrilex Coated Fruitnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0346 |
| Rugby Nicotine Polacrilex Gum, Coated Fruit Flavornicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3386 |