Cetirizine Hydrochloride
- Product NDC
- 51655-801
- 11-digit product format
- 516550801
- Labeler code
- 51655
- Product ID
- 51655-801_4ba8e808-dc3c-03b9-e063-6394a90a61a2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2023-01-25
- 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 | 1014678 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-801-52 | 51655080152 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-52) | 2023-01-25 | No | No | Historical |
| 51655-801-60 | 51655080160 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-60) | 2023-01-25 | No | No | Historical |
| 51655-801-84 | 51655080184 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-84) | 2023-01-25 | No | No | Historical |