Cetirizine Hydrochloride
- Product NDC
- 71205-709
- 11-digit product format
- 712050709
- Labeler code
- 71205
- Product ID
- 71205-709_bb392ca5-d39d-4265-95b2-bc44e133101b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2018-12-17
- 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
openFDA Listing Details
- Product ID
- 71205-709_bb392ca5-d39d-4265-95b2-bc44e133101b
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- Generic name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2018-12-17
- Marketing category
- ANDA
- Application number
- ANDA078343
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678 |
| Spl Set Id | 55b1738c-fa72-4cd1-a8e8-be41b12b593d |
| Manufacturer Name | Proficient Rx LP |
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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-709-00 | 71205070900 | 100 TABLET, FILM COATED in 1 BOTTLE (71205-709-00) | 2025-07-08 | | No | No | Current |
| 71205-709-06 | 71205070906 | 6 TABLET, FILM COATED in 1 BOTTLE (71205-709-06) | 2022-10-31 | 0000-00-00 | No | No | Current |
| 71205-709-10 | 71205070910 | 10 TABLET, FILM COATED in 1 BOTTLE (71205-709-10) | 2022-10-31 | 0000-00-00 | No | No | Current |
| 71205-709-14 | 71205070914 | 14 TABLET, FILM COATED in 1 BOTTLE (71205-709-14) | 2022-10-31 | 0000-00-00 | No | No | Current |
| 71205-709-20 | 71205070920 | 20 TABLET, FILM COATED in 1 BOTTLE (71205-709-20) | 2026-03-04 | 0000-00-00 | No | No | Current |
| 71205-709-30 | 71205070930 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-709-30) | 2022-10-31 | 0000-00-00 | No | No | Current |
| 71205-709-60 | 71205070960 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-709-60) | 2022-10-31 | 0000-00-00 | No | No | Current |
| 71205-709-90 | 71205070990 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-709-90) | 2022-10-31 | 0000-00-00 | No | No | Current |