Cetirizine hydrochloride
- Product NDC
- 0615-8479
- 11-digit product format
- 006158479
- Labeler code
- 0615
- Product ID
- 0615-8479_1125df7c-ba82-46fe-a411-05322146a3b9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2022-01-13
- 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 | 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8479-39 | Cetirizine hydrochloride | 30 in 1 BLISTER PACK | TABLET, COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8479 | CETIRIZINE HYDROCHLORIDE TABLET, COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 2 | Current NDC, 1 package rows | 20240625_b53d5e8a-a30c-4025-aa72-d2776a112e3e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8479-39 | 00615847939 | 30 TABLET, COATED in 1 BLISTER PACK (0615-8479-39) | 2023-07-31 | No | No | Current |