Cetirizine hydrochloride and Pseudoephedrine hydrochloride
- Product NDC
- 45802-147
- 11-digit product format
- 458020147
- Labeler code
- 45802
- Product ID
- 45802-147_1e179f00-1e00-4199-bf78-bb00aa268c74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride, Pseudoephedrine hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA210719
- Marketing category
- ANDA
- Marketing start
- 2020-03-31
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine hydrochloride and Pseudoephedrine hydrochloride
- Listing expiration
- 2026-12-31
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-147-53 | Cetirizine hydrochloride and Pseudoephedrine hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 5 |
| 45802-147-53 | Cetirizine hydrochloride and Pseudoephedrine hydrochloride | 12 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 12 | | 5 |
| 45802-147-62 | Cetirizine hydrochloride and Pseudoephedrine hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 5 |
| 45802-147-62 | Cetirizine hydrochloride and Pseudoephedrine hydrochloride | 24 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 24 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-147 | CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250214_3260111b-35da-4f95-8081-51eae4b1ef45.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 |
|---|
| 45802-147-53 | 45802014753 | 12 BLISTER PACK in 1 CARTON (45802-147-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 12 blister pack | 2020-03-31 | 0000-00-00 | No | No | Current |
| 45802-147-62 | 45802014762 | 24 BLISTER PACK in 1 CARTON (45802-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 24 blister pack | 2020-03-31 | 0000-00-00 | No | No | Current |