Cetirizine Hydrochloride
- Product NDC
- 53943-519
- 11-digit product format
- 539430519
- Labeler code
- 53943
- Product ID
- 53943-519_5c71a4a6-cf88-4fdc-db4f-23235af0306b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Discount Drug Mart, Inc
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2020-01-20
- 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 |
|---|
| 53943-519-30 | Cetirizine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
| 53943-519-30 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 53943-519-45 | Cetirizine Hydrochloride | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 4 |
| 53943-519-45 | Cetirizine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53943-519 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DISCOUNT DRUG MART, INC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20231009_c7c7e496-3682-c764-88ef-d2a09823f71e.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 |
|---|
| 53943-519-30 | 53943051930 | 1 BOTTLE in 1 CARTON (53943-519-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-01-20 | 0000-00-00 | No | No | Current |
| 53943-519-45 | 53943051945 | 1 BOTTLE in 1 CARTON (53943-519-45) / 45 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-01-20 | 0000-00-00 | No | No | Current |