Over-the-counter drug · ANDA
Nicotine Polacrilex Original Flavor NDC 56062-608
nicotine polacrilex · Nicotine 2 mg/1 · Gum, Chewing · Buccal · Publix Supermarkets, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 56062-608-62 | 56062060862 | 11 BLISTER PACK in 1 CARTON (56062-608-62) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Original FlavorSuffix: Original Flavor
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- Publix Supermarkets, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074507
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 56062-608_35b42ef4-7ba7-45e0-b2ba-a47915781e04SPL ID 35b42ef4-7ba7-45e0-b2ba-a47915781e04SPL set ID 540c88bd-70dc-416a-8d8e-0a33b2b29563RxCUI 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
N456062060862followed by a unit qualifier and the quantityPackage 56062-0608-62. 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.
Other NDCs under ANDA 074507
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, Originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-286 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | The Kroger Co. | 30142-859 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | McKesson Corporation dba SKY Packaging | 63739-371 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-1608 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-9290 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3029 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-608 |
| Nicotine Polacrilex Originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0345 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | P & L Development, LLC | 59726-929 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-719 |