Over-the-counter drug · ANDA
Medline (Nicotine) NDC 53329-193
Nicotine 7 mg/1 · Patch · Transdermal · Medline Industries, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53329-193-89 | 53329019389 | 14 POUCH in 1 CARTON (53329-193-89) / 1 PATCH in 1 POUCH (53329-193-09)Marketed from Aug 28, 2022 |
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)
- Medline
- Generic name (nonproprietary)
- nicotine
- Active ingredients
- Nicotine — 7 mg/1
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Medline Industries, LPNDC labeler code 53329
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074645
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 53329-193_42c99420-c566-55f4-e063-6294a90ad873SPL ID 42c99420-c566-55f4-e063-6294a90ad873SPL set ID e11a4b7e-6f1f-24db-e053-2a95a90a0d09RxCUI 198029, 198030, 198031UNII 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N453329019389followed by a unit qualifier and the quantityPackage 53329-0193-89. 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 53329-193
- What is NDC 53329-193?
- 53329-193 is the product NDC for Medline (nicotine), Nicotine 7 mg/1 patch, listed with the FDA by Medline Industries, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Medline (Nicotine).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Medline?
- 47 other product NDCs are listed under this name. See all Medline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Medline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Medlineacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Medline Industries, LP | 53329-199 | 53329-0199-09 |
| Medlineacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | Medline Industries, LP | 53329-221 | 53329-0221-09 |
| Medlineaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Medline Industries, LP | 53329-601 | 53329-0601-09 |
| Medlineiburprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Medline Industries, LP | 53329-603 | 53329-0603-09 |
| Medlineacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Medline Industries, LP | 53329-605 | 53329-0605-09 |
| Medlinemiconazole nitrate | Miconazole nitrate 20 mg/g | OintmentTopical | Medline Industries, LP | 53329-256 | 53329-0256-1453329-0256-64 |
| Medlineacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Medline Industries, LP | 53329-604 | 53329-0604-30 |
| Medlinedimethicone | Dimethicone 1.575 g/100mL | CreamTopical | Medline Industries, LP | 53329-271 | 53329-0271-4453329-0271-86 |
| Medlineaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Medline Industries, LP | 53329-600 | 53329-0600-67 |
| Medlinewhite petrolatum | White petrolatum 86.5 g/100g | OintmentTopical | Medline Industries, LP | 53329-257 | 53329-0257-1053329-0257-74 |