Over-the-counter drug · ANDA
berkley and jensen nicotine (Nicotine polacrilex) NDC 68391-170
Nicotine 4 mg/1 · Gum, Chewing · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-170-36 | 6839101703668391017036 | 2 CARTON in 1 CARTON (68391-170-36) / 160 BLISTER PACK in 1 CARTON (68391-170-06) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Nov 16, 2016 |
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
- Gum, Chewing
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- 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 68391-170_f5be4a84-e8df-424f-b85c-0e59e730c9f8SPL ID f5be4a84-e8df-424f-b85c-0e59e730c9f8
- 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
N468391017036followed by a unit qualifier and the quantityPackage 68391-0170-36. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68391-170
- What is NDC 68391-170?
- 68391-170 is the product NDC for berkley and jensen nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by BJWC. It has 1 package NDC, 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 4 mg/1 | LozengeOral | BJWC | 68391-957 | 68391-0957-0168391-0957-06 |
| 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 |
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 |
| 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 |
| signature care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Safeway | 21130-522 |
| 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 |