Over-the-counter drug · ANDA
berkley and jensen nicotine polacrilex (Nicotine polacrilex) NDC 68391-873
Nicotine 4 mg/1 · Lozenge · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-873-13 | 6839108731368391087313 | 7 CONTAINER in 1 CARTON (68391-873-13) / 27 LOZENGE in 1 CONTAINERMarketed from Nov 23, 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 polacrilex
- 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 077007
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 68391-873_1b1ebcd0-e7ac-4c86-a922-fd02744b427eSPL ID 1b1ebcd0-e7ac-4c86-a922-fd02744b427eSPL set ID b586ce1c-77cd-497c-b22c-8c97f54583baRxCUI 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
N468391087313followed by a unit qualifier and the quantityPackage 68391-0873-13. 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 68391-873
- What is NDC 68391-873?
- 68391-873 is the product NDC for berkley and jensen nicotine polacrilex, Nicotine 4 mg/1 lozenge, 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 polacrilex (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 polacrilex?
- 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 077007
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 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-344 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-492 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-509 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-873 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | BJWC | 68391-344 |
| care one nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | American Sales Company | 41520-873 |
| careone nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | American Sales Company | 41520-701 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-873 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-998 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-182 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-353 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-354 |
| euqate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-101 |
| exchange select nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-617 |
| exchange select nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Army & Air Force Exchange Service | 55301-873 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Strategic Sourcing Services LLC | 70677-1176 |
| foster and thrive nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Strategic Sourcing Services LLC | 70677-1177 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-0344 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-0873 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-2502 |
Showing 20 of 39.