Over-the-counter drug · ANDA
berkley and jensen nicotine (Nicotine polacrilex) NDC 68391-957
Nicotine 4 mg/1 · Lozenge · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-957-01 | 68391095701 | 27 LOZENGE in 1 BOTTLE (68391-957-01)Marketed from Nov 6, 2017 | |
| 68391-957-06 | 68391095706 | 7 BOTTLE in 1 PACKAGE (68391-957-06) / 27 LOZENGE in 1 BOTTLEMarketed from Nov 6, 2017 |
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)
- berkley and jensen nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- 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 68391-957_357123fc-0972-4683-ab52-f95d46c1b6c9SPL ID 357123fc-0972-4683-ab52-f95d46c1b6c9SPL set ID 357123fc-0972-4683-ab52-f95d46c1b6c9RxCUI 359818UNII 6M3C89ZY6RUPC 0012345678905
- 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
N468391095701followed by a unit qualifier and the quantityPackage 68391-0957-01. 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 68391-957
- What is NDC 68391-957?
- 68391-957 is the product NDC for berkley and jensen nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by BJWC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- berkley and jensen nicotine (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for berkley and jensen nicotine?
- 6 other product NDCs are listed under this name. See all berkley and jensen nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other berkley and jensen 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) |
|---|---|---|---|---|---|
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | BJWC | 68391-734 | 68391-0734-06 |
| Berkley and Jensen NICOTINEnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | BJWC | 68391-012 | 68391-0012-70 |
| Berkley and Jensen Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | BJWC | 68391-309 | 68391-0309-70 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | BJWC | 68391-344 | 68391-0344-13 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | BJWC | 68391-029 | 68391-0029-0668391-0029-36 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | BJWC | 68391-170 | 68391-0170-36 |
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 |
|---|---|---|---|---|
| Nicotine Mininicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-569 |
| mini nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer, Inc. | 79481-0734 |
| up and up nicotine mini mintnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Target Corporation | 82442-957 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | BJWC | 68391-734 |
| members mark Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Sam's West Inc | 68196-734 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-957 |
| members mark nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Sam's West Inc | 68196-811 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-0957 |
| Quitine Mini Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | QUITINE LLC | 84720-034 |
| quitine mini nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | QUITINE LLC | 84720-009 |
| mini nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-587 |
| members mark mini nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Sam's West Inc | 68196-957 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Topco Associates LLC | 36800-957 |
| Nicotine | Nicotine 2 mg/1 | LozengeOral | H E B | 37808-900 |
| Rexall Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dolgencorp, LLC | 55910-957 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-642 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Kroger Company | 30142-696 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | LozengeOral | Padagis Israel Pharmaceuticals Ltd | 45802-957 |
| Mini Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer, Inc. | 79481-0957 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-734 |
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