ZYRTEC-D
- Product NDC
- 50580-719
- 11-digit product format
- 505800719
- Labeler code
- 50580
- Product ID
- 50580-719_4ec5aa70-7743-2cf9-e063-6394a90a06dd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA021150
- Marketing category
- NDA
- Marketing start
- 2023-02-28
- Substance
- CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 5; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZYRTEC-D
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA, 6V9V2RYJ8N |
| Rxcui | 1014571, 1014583 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-719-12 | ZYRTEC-D | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | | 6 |
| 50580-719-12 | ZYRTEC-D | 6 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 6 | | 6 |
| 50580-719-24 | ZYRTEC-D | 4 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 4 | | 6 |
| 50580-719-24 | ZYRTEC-D | 6 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-719 | ZYRTEC-D (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [KENVUE BRANDS LLC] | 4 | Current NDC, 4 package rows | 20250323_f1ecf9ba-1c03-7fb7-e053-2a95a90a875a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50580-719-12 | 50580071912 | 2 BLISTER PACK in 1 CARTON (50580-719-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2023-02-28 | No | No | Historical |
| 50580-719-24 | 50580071924 | 4 BLISTER PACK in 1 CARTON (50580-719-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2023-02-28 | No | No | Historical |