Cetirizine Hydrochloride
- Product NDC
- 0363-0471
- 11-digit product format
- 003630471
- Labeler code
- 0363
- Product ID
- 0363-0471_b8e38b9c-29f4-4f19-b1e9-e14c3926b7a9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- WALGREEN CO.
- Application
- ANDA213557
- Marketing category
- ANDA
- Marketing start
- 2020-09-11
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 0363-0471-76 | Cetirizine Hydrochloride | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 7 |
| 0363-0471-76 | Cetirizine Hydrochloride | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-0471 | CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [WALGREEN CO.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250202_9e728bf2-0cb9-ecf5-e053-2a95a90a408a.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 |
|---|
| 0363-0471-76 | 00363047176 | 4 BLISTER PACK in 1 CARTON (0363-0471-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 blister pack | 2020-09-11 | 0000-00-00 | No | No | Current |