Over-the-counter drug · ANDA
equate nicotine (Nicotine polacrilex) NDC 49035-415
Nicotine 2 mg/1 · Gum, Chewing · Oral · Wal-Mart Stores Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49035-415-78 | 4903504157849035041578 | 100 BLISTER PACK in 1 CARTON (49035-415-78) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Apr 4, 2020 |
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)
- equate nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Wal-Mart Stores IncNDC labeler code 49035
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206394
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 49035-415_1adb5d01-d1a2-4776-886f-009eb87d0fc8SPL ID 1adb5d01-d1a2-4776-886f-009eb87d0fc8SPL set ID 2eca67db-1b7c-43dd-91af-4060e9b8e9d3RxCUI 314119UNII 6M3C89ZY6R
- 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
N449035041578followed by a unit qualifier and the quantityPackage 49035-0415-78. 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 49035-415
- What is NDC 49035-415?
- 49035-415 is the product NDC for equate nicotine (nicotine polacrilex), Nicotine 2 mg/1 gum, chewing, listed with the FDA by Wal-Mart Stores Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- equate nicotine (Nicotine polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Wal-Mart Stores Inc, NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for equate nicotine?
- 25 other product NDCs are listed under this name. See all equate nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other equate 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) |
|---|---|---|---|---|---|
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-354 | 79903-0354-2079903-0354-80 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-353 | 79903-0353-2079903-0353-80 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-182 | 79903-0182-2079903-0182-80 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-104 | 79903-0104-0879903-0104-27 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-160 | 79903-0160-0879903-0160-27 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-309 | 49035-0309-78 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-791 | 49035-0791-10 |
| Equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-900 | 49035-0900-10 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-201 | 49035-0201-0949035-0201-10 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-702 | 49035-0702-10 |
Other NDCs under ANDA 206394
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 2 mg/1 | Gum, ChewingOral | HyVee Inc | 42507-343 |
| HEB Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | H E B | 37808-863 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | H E B | 37808-909 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7269 |
| Topcare Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-460 |
| careone nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | American Sales Company | 41520-711 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-646 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7050 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Kroger Company | 30142-749 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Padagis Israel Pharmaceuticals Ltd | 45802-827 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-1012 |
| Foster and Thrive Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Strategic Sourcing Services LLC | 70677-1192 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-811 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-012 |
| Members Mark Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-012 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-269 |
| Quitine Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-012 |
| Berkley and Jensen NICOTINEnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | BJWC | 68391-012 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-209 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-292 |
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