Over-the-counter drug · ANDA
nicotine (nicotine polacrilex) NDC 0363-0124
Nicotine 2 mg/1 · Lozenge · Oral · Walgreen Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0124-05 | 00363012405 | 3 CONTAINER in 1 CARTON (0363-0124-05) / 24 LOZENGE in 1 CONTAINER (0363-0124-03)Marketed from Sep 15, 2009 | |
| 0363-0124-10 | 00363012410 | 4 CONTAINER in 1 CARTON (0363-0124-10) / 27 LOZENGE in 1 CONTAINER (0363-0124-09)Marketed from Sep 16, 2009 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Walgreen Company
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090711
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-0124_0ba190cf-8759-426e-aad1-9a9429c80842SPL ID 0ba190cf-8759-426e-aad1-9a9429c80842SPL set ID 4a81d378-009d-43a9-a895-e371ffa700e9RxCUI 359817UNII 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
N400363012405followed by a unit qualifier and the quantityPackage 00363-0124-05. 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.
Other NDCs under ANDA 090711
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 | Nicotine 4 mg/1 | LozengeOral | H E B | 37808-383 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-4190 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-700 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-190 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rite Aid Corporation | 11822-0124 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Topco Associates LLC | 36800-539 |
| Kirkland Signature Nicotinenicotine | Nicotine 4 mg/1 | LozengeOral | Costco Wholesale Company | 63981-190 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Kroger Company | 30142-124 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-190 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 59779-397 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-771 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-124 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Kroger Company | 30142-190 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-190 |
| nicotine | Nicotine 2 mg/1 | LozengeOral | H E B | 37808-533 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-124 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-190 |
| Kirkland Signature Nicotinenicotine | Nicotine 2 mg/1 | LozengeOral | Costco Wholesale Company | 63981-124 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-1125 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-499 |
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