Nicotine
- Product NDC
- 11822-4975
- 11-digit product format
- 118224975
- Labeler code
- 11822
- Product ID
- 11822-4975_31036926-dedd-9ff4-05eb-ebc5a28af900
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Rite Aid Corporation
- Application
- NDA020076
- Marketing category
- NDA
- Marketing start
- 2015-05-14
- Substance
- NICOTINE
- Active strength
- 21 mg/24h
- 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
- Nicotine
- Brand name suffix
- transdermal system step 1
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 21 mg/24h |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 198029, 198030, 198031 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11822-4975 | NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [RITE AID CORPORATION] | 7 | Current NDC, Legacy NDC | 20240727_d2e32434-ec58-943e-dbeb-8e7331531595.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 |
|---|
| 11822-4975-0 | 11822497500 | 7 PATCH in 1 CARTON (11822-4975-0) / 24 h in 1 PATCH | 7 patch | 2015-05-14 | 0000-00-00 | No | No | Current |
| 11822-4975-1 | 11822497501 | 14 PATCH in 1 CARTON (11822-4975-1) / 24 h in 1 PATCH | 14 patch | 2015-05-14 | 0000-00-00 | No | No | Current |
| 11822-4975-2 | 11822497502 | 2 PATCH in 1 CARTON (11822-4975-2) / 24 h in 1 PATCH | 2 patch | 2015-05-14 | 0000-00-00 | No | No | Current |