cetirizine hydrochloride
- Product NDC
- 45802-919
- 11-digit product format
- 458020919
- Labeler code
- 45802
- Product ID
- 45802-919_431bdf74-dfe3-4e4f-91e9-2b638ada6d47
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA078336
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- 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 |
|---|
| 45802-919-39 | cetirizine hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 45802-919-39 | cetirizine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 45802-919-87 | cetirizine hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 45802-919-87 | cetirizine hydrochloride | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-919 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250313_91fe3ab8-c155-4482-9f06-f029d3563aad.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 |
|---|
| 45802-919-39 | 45802091939 | 1 BOTTLE in 1 CARTON (45802-919-39) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2008-10-15 | 0000-00-00 | No | No | Current |
| 45802-919-87 | 45802091987 | 1 BOTTLE in 1 CARTON (45802-919-87) / 300 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2007-12-27 | 0000-00-00 | No | No | Current |