Cetirizine Hydrochloride (Allergy)
- Product NDC
- 58602-823
- 11-digit product format
- 586020823
- Labeler code
- 58602
- Product ID
- 58602-823_bd9c2a41-9024-46a4-87c6-7d6f5f1fafbf
- 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
- 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 (Allergy)
- 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 | 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-823-09 | Cetirizine Hydrochloride (Allergy) | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 58602-823-09 | Cetirizine Hydrochloride (Allergy) | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 58602-823-19 | Cetirizine Hydrochloride (Allergy) | 1 in 1 CARTON | TABLET | 1 | | 4 |
| 58602-823-19 | Cetirizine Hydrochloride (Allergy) | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
| 58602-823-39 | Cetirizine Hydrochloride (Allergy) | 365 in 1 BOTTLE | TABLET | 365 | | 4 |
| 58602-823-39 | Cetirizine Hydrochloride (Allergy) | 1 in 1 CARTON | TABLET | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-823 | CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240120_7d214cba-951d-464e-b37e-e83098944fe6.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 |
|---|
| 58602-823-09 | 58602082309 | 1 BOTTLE in 1 CARTON (58602-823-09) > 30 TABLET in 1 BOTTLE | 1 bottle | 2015-08-05 | 0000-00-00 | No | No | Current |
| 58602-823-19 | 58602082319 | 1 BOTTLE in 1 CARTON (58602-823-19) > 90 TABLET in 1 BOTTLE | 1 bottle | 2015-08-05 | 0000-00-00 | No | No | Current |
| 58602-823-39 | 58602082339 | 1 BOTTLE in 1 CARTON (58602-823-39) / 365 TABLET in 1 BOTTLE | 1 bottle | 2015-08-05 | 0000-00-00 | No | No | Current |