Cetirizine Hydrochloride (Allergy)
- Product NDC
- 58602-444
- 11-digit product format
- 586020444
- Labeler code
- 58602
- Product ID
- 58602-444_146cd9eb-d2c1-4424-9e37-350004f18507
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA090760
- Marketing category
- ANDA
- Marketing start
- 2015-08-05
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 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 (Allergy)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014676, 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-444-09 | Cetirizine Hydrochloride (Allergy) | 1 in 1 CARTON | TABLET | 1 | | 11 |
| 58602-444-09 | Cetirizine Hydrochloride (Allergy) | 30 in 1 BOTTLE | TABLET | 30 | | 11 |
| 58602-444-17 | Cetirizine Hydrochloride (Allergy) | 45 in 1 BOTTLE | TABLET | 45 | | 11 |
| 58602-444-17 | Cetirizine Hydrochloride (Allergy) | 1 in 1 CARTON | TABLET | 1 | | 11 |
| 58602-444-21 | Cetirizine Hydrochloride (Allergy) | 10 in 1 CARTON | TABLET | 10 | | 11 |
| 58602-444-21 | Cetirizine Hydrochloride (Allergy) | 10 in 1 BLISTER PACK | TABLET | 10 | | 11 |
| 58602-444-41 | Cetirizine Hydrochloride (Allergy) | 1000 in 1 BOTTLE | TABLET | 1000 | | 11 |
| 58602-444-47 | Cetirizine Hydrochloride (Allergy) | 75 in 1 PACKAGE, COMBINATION | TABLET | 75 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-444 | CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC] | 11 | Current NDC, Legacy NDC, 8 package rows | 20240915_3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25.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 |
|---|
| 58602-444-09 | 58602044409 | 1 BOTTLE in 1 CARTON (58602-444-09) / 30 TABLET in 1 BOTTLE | 1 bottle | 2015-08-05 | 0000-00-00 | No | No | Current |
| 58602-444-17 | 58602044417 | 1 BOTTLE in 1 CARTON (58602-444-17) / 45 TABLET in 1 BOTTLE | 1 bottle | 2015-08-05 | 0000-00-00 | No | No | Current |
| 58602-444-21 | 58602044421 | 10 BLISTER PACK in 1 CARTON (58602-444-21) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2015-08-05 | 0000-00-00 | No | No | Current |
| 58602-444-41 | 58602044441 | 1000 TABLET in 1 BOTTLE (58602-444-41) | 1000 tablet | 2015-08-05 | 0000-00-00 | No | No | Current |
| 58602-444-47 | 58602044447 | 75 TABLET in 1 PACKAGE, COMBINATION (58602-444-47) | 75 tablet | 2015-08-05 | 0000-00-00 | No | No | Current |