Cetirizine Hydrochloride
- Product NDC
- 54838-571
- 11-digit product format
- 548380571
- Labeler code
- 54838
- Product ID
- 54838-571_083a0699-dc95-44fc-880d-168a6058d0a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA078876
- Marketing category
- ANDA
- Marketing start
- 2012-05-11
- Marketing end
- 2023-11-30
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54838-571-40 | 54838057140 | 120 mL in 1 BOTTLE, PLASTIC (54838-571-40) | 120 ml | 2012-05-11 | 2023-11-30 | No | No | Current |
| 54838-571-80 | 54838057180 | 473 mL in 1 BOTTLE, PLASTIC (54838-571-80) | 473 ml | 2012-05-11 | 2023-11-30 | No | No | Current |