Cetirizine Hydrochloride
- Product NDC
- 58602-862
- 11-digit product format
- 586020862
- Labeler code
- 58602
- Product ID
- 58602-862_c6f65c7b-e626-4ef3-910d-03702cac03bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA213557
- Marketing category
- ANDA
- Marketing start
- 2021-02-18
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1011482 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-862-76 | Cetirizine Hydrochloride | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 2 |
| 58602-862-76 | Cetirizine Hydrochloride | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-862 | CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [AUROHEALTH LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20210508_d9ebebb5-736a-4019-8c1a-030148de9d02.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 |
|---|
| 58602-862-76 | 58602086276 | 4 BLISTER PACK in 1 CARTON (58602-862-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 blister pack | 2021-02-18 | 0000-00-00 | No | No | Current |