Over-the-counter drug · ANDA
signature care nicotine (nicotine polacrilex) NDC 21130-522
Nicotine 4 mg/1 · Gum, Chewing · Oral · Safeway
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-522-25 | 21130052225 | 110 BLISTER PACK in 1 CARTON (21130-522-25) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Oct 9, 2018 |
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)
- signature care nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Safeway
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076789
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 21130-522_bb553fe9-d772-4de4-b2ac-1364ba5699b5SPL ID bb553fe9-d772-4de4-b2ac-1364ba5699b5SPL set ID 3591828f-dff0-4cb7-ab0e-d43704243dc2RxCUI 311975UNII 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
N421130052225followed by a unit qualifier and the quantityPackage 21130-0522-25. 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 076789
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 |
|---|---|---|---|---|
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-0170 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Rite Aid Corporation | 11822-0170 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-170 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-170 |
| careone nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | American Sales Company | 41520-891 |
| Equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-170 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-170 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Strategic Sourcing Services LLC | 70677-1167 |
| kirkland signature quit 4nicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-170 |
| up and up uncoated original nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-170 |
| members mark nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-170 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | BJWC | 68391-170 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-812 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | H E B | 37808-849 |