Medline
- Product NDC
- 53329-191
- 11-digit product format
- 533290191
- Labeler code
- 53329
- Product ID
- 53329-191_42c99420-c566-55f4-e063-6294a90ad873
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Medline Industries, LP
- Application
- ANDA074611
- Marketing category
- ANDA
- Marketing start
- 2022-06-30
- Substance
- NICOTINE
- Active strength
- 14 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Medline
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 14 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 198029, 198030, 198031 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53329-191-09 | Medline | 1 in 1 POUCH | PATCH | 1 | | 8 |
| 53329-191-89 | Medline | 14 in 1 CARTON | PATCH | 14 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53329-191 | MEDLINE (NICOTINE) PATCH [MEDLINE INDUSTRIES, LP] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250327_e11a4b7e-6f1f-24db-e053-2a95a90a0d09.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53329-191-09 | 53329019109 | 1 in 1 POUCH | | | | | | Historical |
| 53329-191-89 | 53329019189 | 14 POUCH in 1 CARTON (53329-191-89) / 1 PATCH in 1 POUCH (53329-191-09) | 14 pouch | 2022-08-28 | 0000-00-00 | No | No | Current |