Over-the-counter drug · ANDA
Nicotine Polacrilex Original (Nicotine polacrilex) NDC 70000-0341
Nicotine 4 mg/1 · Gum, Chewing · Buccal · CARDINAL HEALTH 110, LLC. DBA LEADER 70000
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0341-1 | 7000003410170000034101 | 50 BLISTER PACK in 1 CARTON (70000-0341-1) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 3, 2018 |
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 Polacrilex OriginalSuffix: Original
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADER 70000NDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074707
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 70000-0341_905563ef-1910-4436-a4cd-351213b503afSPL ID 905563ef-1910-4436-a4cd-351213b503afSPL set ID 4acbda22-9c87-49f2-ad5f-55b1e54bdf2eRxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0096295133837, 0096295133844
- 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470000034101followed by a unit qualifier and the quantityPackage 70000-0341-01. 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 70000-0341
- What is NDC 70000-0341?
- 70000-0341 is the product NDC for Nicotine Polacrilex Original (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by CARDINAL HEALTH 110, LLC. DBA LEADER 70000. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine Polacrilex Original (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- CARDINAL HEALTH 110, LLC. DBA LEADER 70000, NDC labeler code 70000. 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 Polacrilex Original?
- 7 other product NDCs are listed under this name. See all Nicotine Polacrilex Original NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Polacrilex Original products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotine Polacrilex Originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0345 | 70000-0345-01 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-1608 | 00363-1608-6200363-1608-98 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Walgreens | 0363-1609 | 00363-1609-6200363-1609-98 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-608 | 69842-0608-1569842-0608-5069842-0608-79+1 more |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-609 | 69842-0609-1569842-0609-5069842-0609-79+1 more |
| Nicotine Polacrilex, Originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-286 | 68016-0286-62 |
| Nicotine Polacrilex, Originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-287 | 68016-0287-62 |
Other NDCs under ANDA 074707
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 | Walgreens | 0363-9350 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3030 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | The Kroger Co. | 30142-671 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-733 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | P & L Development, LLC | 59726-935 |
| Nicotine Polacrilex Origianl Flavornicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-609 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Walgreens | 0363-1609 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-609 |
| Nicotine Polacrilex, Originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-287 |
| Rugby Nicotine Polacrilex Gum, Original Flavornicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | ATLANTIC BIOLOGICALS CORP. | 17856-3030 |