Over-the-counter drug · ANDA
nicotine (Nicotine polacrilex) NDC 11822-0971
Nicotine 4 mg/1 · Gum, Chewing · Oral · Rite Aid Corporation
NDC codes
FDA NDC DirectoryProduct NDC (as listed)11822-0971Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11822-0971Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11822-0971-1 | 1182209710111822097101 | 20 BLISTER PACK in 1 CARTON (11822-0971-1) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 11, 2020 | |
| 11822-0971-2 | 1182209710211822097102 | 160 BLISTER PACK in 1 CARTON (11822-0971-2) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Mar 27, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Rite Aid CorporationNDC labeler code 11822
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206393
- Marketing start
- Marketing end
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 11822-0971_20ab08c5-72b6-49f4-944e-c08ff97cf4a3SPL ID 20ab08c5-72b6-49f4-944e-c08ff97cf4a3SPL set ID 9d315243-b55e-4277-b0c2-83e7b5fe504cRxCUI 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
N411822097101followed by a unit qualifier and the quantityPackage 11822-0971-01. 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 11822-0971
- What is NDC 11822-0971?
- 11822-0971 is the product NDC for nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Rite Aid Corporation. It has 2 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?
- Rite Aid Corporation, NDC labeler code 11822. 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 206393
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 |
|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-863 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7103 |
| Berkley and Jensen Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | BJWC | 68391-309 |
| members mark nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-309 |
| Up And Up Coated Cinnamon Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-329 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-650 |
| Up and Up Mint Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-500 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | H E B | 37808-611 |
| kirkland signature quit 4nicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-309 |
| up and up coated mint freeze nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-723 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Kroger Company | 30142-309 |
| Members Mark Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-971 |
| signature care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Safeway | 21130-173 |
| signature care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Safeway | 21130-820 |
| Up And Up Coated Fruit Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-971 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | H E B | 37808-683 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-019 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-510 |
| nicotine | Nicotine 4 mg/1 | Gum, ChewingOral | H E B | 37808-739 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-8600 |
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