Over-the-counter drug · ANDA
members mark mini nicotine (Nicotine polacrilex) NDC 68196-957
Nicotine 4 mg/1 · Lozenge · Oral · Sam's West Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68196-957-07 | 6819609570768196095707 | 8 CONTAINER in 1 CARTON (68196-957-07) / 27 LOZENGE in 1 CONTAINER (68196-957-01)Marketed from Feb 24, 2020 |
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)
- members mark mini nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Sam's West IncNDC labeler code 68196
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203690
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 68196-957_67fdfdbd-173e-4d18-856c-f9cedb181bbcSPL ID 67fdfdbd-173e-4d18-856c-f9cedb181bbcSPL set ID 5d05f906-8447-43a1-9460-c6da3f3873c7RxCUI 359818UNII 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
N468196095707followed by a unit qualifier and the quantityPackage 68196-0957-07. 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 68196-957
- What is NDC 68196-957?
- 68196-957 is the product NDC for members mark mini nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Sam's West Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- members mark mini nicotine (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Sam's West Inc, NDC labeler code 68196. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for members mark mini nicotine?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 203690
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 |
|---|---|---|---|---|
| Up and Up Mini Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Target Corporation | 82442-802 |
| members mark nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Sam's West Inc | 68196-084 |
| up and up citrus mini nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Target Corporation | 82442-399 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-957 |
| Nicotine Mininicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Kroger Company | 30142-209 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-223 |
| nicotine mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-789 |
| nicotine mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-797 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-957 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-808 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | H E B | 37808-563 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-0957 |
| up and up mint mini nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Target Corporation | 82442-734 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-734 |
| mini nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer, Inc. | 79481-0734 |
| members mark Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Sam's West Inc | 68196-734 |
| nicotine | Nicotine 4 mg/1 | LozengeOral | CVS Pharmacy | 69842-828 |
| members mark nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Sam's West Inc | 68196-811 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | H E B | 37808-617 |
| Topcare Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Topco Associates LLC | 36800-734 |
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