Cetirizine Hydrochloride
- Product NDC
- 55289-995
- 11-digit product format
- 552890995
- Labeler code
- 55289
- Product ID
- 55289-995_4d6247d2-324f-cecb-e063-6394a90a876e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077498
- 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
- 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 |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 64O047KTOA | CETIRIZINE HYDROCHLORIDE | 83881-52-1 | CETIRIZINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-995-07 | 55289099507 | 7 TABLET in 1 BOTTLE, PLASTIC (55289-995-07) | 7 tablet | 2022-03-08 | 0000-00-00 | No | No | Current |
| 55289-995-10 | 55289099510 | 10 TABLET in 1 BOTTLE, PLASTIC (55289-995-10) | 10 tablet | 2022-08-09 | 0000-00-00 | No | No | Current |
| 55289-995-30 | 55289099530 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-995-30) | 30 tablet | 2018-04-26 | 0000-00-00 | No | No | Current |
| 55289-995-90 | 55289099590 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-995-90) | 90 tablet | 2018-04-26 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | 2026-03-19 | HUMAN OTC DRUG LABEL | 15 |