Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 0536-1279
- 11-digit product format
- 005361279
- Labeler code
- 0536
- Product ID
- 0536-1279_cf50d4ee-e05e-477a-b543-4ba232e53c80
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride, Pseudoephedrine hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rugby Laboratories
- Application
- ANDA210719
- Marketing category
- ANDA
- Marketing start
- 2020-03-09
- 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
- Rugby 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 |
|---|
| 0536-1279-12 | Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
| 0536-1279-12 | Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | 12 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 12 | | 3 |
| 0536-1279-35 | Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
| 0536-1279-35 | Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride | 24 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 24 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1279 | RUGBY CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [RUGBY LABORATORIES] | 3 | Current NDC, Legacy NDC, 4 package rows | 20250214_5c6ac9a2-4f0a-4297-9b83-988d54598f75.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 |
|---|
| 0536-1279-12 | 00536127912 | 12 BLISTER PACK in 1 CARTON (0536-1279-12) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 12 blister pack | 2020-03-09 | 0000-00-00 | No | No | Current |
| 0536-1279-35 | 00536127935 | 24 BLISTER PACK in 1 CARTON (0536-1279-35) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 24 blister pack | 2020-03-09 | 0000-00-00 | No | No | Current |