Cetirizine Hydrochloride
- Product NDC
- 51660-066
- 11-digit product format
- 516600066
- Labeler code
- 51660
- Product ID
- 51660-066_1ae46a4b-8176-44fc-bc57-ed9e62c02746
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- OHM LABORATORIES INC.
- Application
- ANDA090142
- Marketing category
- ANDA
- Marketing start
- 2022-07-21
- 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
- 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 | 1014674 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51660-066-30 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 1 |
| 51660-066-30 | Cetirizine Hydrochloride | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51660-066 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [OHM LABORATORIES INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220731_97802669-b4bd-4807-b3c1-6c6f5a2b0c67.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51660-066-30 | 51660006630 | 1 BOTTLE in 1 CARTON (51660-066-30) / 30 TABLET, CHEWABLE in 1 BOTTLE | 1 bottle | 2022-07-21 | 0000-00-00 | No | No | Current |