Over-the-counter drug · ANDA
Nicotine Polacrilex NDC 0363-9330
Nicotine 4 mg/1 · Gum, Chewing · Oral · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-9330-10 | 00363933010 | 100 BLISTER PACK in 1 CARTON (0363-9330-10) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Oct 30, 2020 | |
| 0363-9330-16 | 00363933016 | 160 BLISTER PACK in 1 CARTON (0363-9330-16) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Oct 30, 2020 | |
| 0363-9330-20 | 00363933020 | 20 BLISTER PACK in 1 CARTON (0363-9330-20) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Oct 30, 2020 |
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
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Walgreens
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078697
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-9330_8c903d99-3418-430d-bac9-a438244b0a06SPL ID 8c903d99-3418-430d-bac9-a438244b0a06SPL set ID 826f63b2-fd18-4213-be38-a430d78897cbRxCUI 311975UNII 6M3C89ZY6RUPC 0311917032764
- 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
N400363933010followed by a unit qualifier and the quantityPackage 00363-9330-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 078697
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 |
|---|---|---|---|---|
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Quitine LLC | 84720-933 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | AAFES/Your Military Exchanges | 55301-429 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-281 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-285 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-976 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-560 |
| Nicotine Polacrilex coated mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-430 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-718 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Rising Pharma Holdings, Inc. | 57237-323 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-933 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-429 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3113 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-796 |
| Habitrol Nicotine Polacrilex Gum 4 mg Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dr. Reddy's Laboratories Inc. | 75907-303 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0343 |