Sudafed Sinus Congestion 12 Hour
- Product NDC
- 50580-242
- 11-digit product format
- 505800242
- Labeler code
- 50580
- Product ID
- 50580-242_216de8df-46aa-927e-e063-6294a90aa11e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2019-06-17
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sudafed Sinus Congestion 12 Hour
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049154, 1049668 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-242-01 | Sudafed Sinus Congestion 12 Hour | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 4 |
| 50580-242-01 | Sudafed Sinus Congestion 12 Hour | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 4 |
| 50580-242-02 | Sudafed Sinus Congestion 12 Hour | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | | 4 |
| 50580-242-02 | Sudafed Sinus Congestion 12 Hour | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 4 |
| 50580-242-03 | Sudafed Sinus Congestion 12 Hour | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 4 |
| 50580-242-03 | Sudafed Sinus Congestion 12 Hour | 3 in 1 PACKAGE | TABLET, FILM COATED, EXTENDED RE | 3 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-242 | SUDAFED SINUS CONGESTION 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [KENVUE BRANDS LLC] | 4 | Current NDC, Legacy NDC, 6 package rows | 20241109_d600b5d5-7d95-4ad6-a95b-6d73502743d7.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 |
|---|
| 50580-242-01 | 50580024201 | 1 BLISTER PACK in 1 CARTON (50580-242-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2019-06-17 | 0000-00-00 | No | No | Current |
| 50580-242-02 | 50580024202 | 2 BLISTER PACK in 1 CARTON (50580-242-02) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2019-06-17 | 0000-00-00 | No | No | Current |
| 50580-242-03 | 50580024203 | 3 CARTON in 1 PACKAGE (50580-242-03) / 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 3 carton | 2019-06-17 | 0000-00-00 | No | No | Current |