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 | 2113005222521130052225 | 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
- SafewayNDC labeler code 21130
- 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.
About NDC 21130-522
- What is NDC 21130-522?
- 21130-522 is the product NDC for signature care nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Safeway. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- signature care nicotine (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for signature care nicotine?
- 7 other product NDCs are listed under this name. See all signature care nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other signature care 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) |
|---|---|---|---|---|---|
| signature care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Safeway | 21130-820 | 21130-0820-78 |
| signature care nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Safeway | 21130-269 | 21130-0269-78 |
| signature care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Safeway | 21130-172 | 21130-0172-02 |
| signature care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Safeway | 21130-185 | 21130-0185-02 |
| signature care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Safeway | 21130-173 | 21130-0173-78 |
| signature care nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Safeway | 21130-186 | 21130-0186-78 |
| signature care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Safeway | 21130-700 | 21130-0700-05 |
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 |
|---|---|---|---|---|
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-170 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | BJWC | 68391-170 |
| 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 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Strategic Sourcing Services LLC | 70677-1167 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-0170 |
| kirkland signature quit 4nicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-170 |
| members mark nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-170 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Rite Aid Corporation | 11822-0170 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | H E B | 37808-849 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-170 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-812 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-170 |
| up and up uncoated original nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-170 |