Cetirizine Hydrochloride
- Product NDC
- 70985-002
- 11-digit product format
- 709850002
- Labeler code
- 70985
- Product ID
- 70985-002_ecfc99f8-fcbd-e91a-e053-2995a90a9e05
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Drug Ocean LLC
- Application
- ANDA077829
- Marketing category
- ANDA
- Marketing start
- 2016-11-08
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70985-002 | CETIRIZINE HYDROCHLORIDE TABLET [DRUG OCEAN LLC] | 5 | Legacy NDC | 20231224_ef78fb17-6905-4961-ab85-7f312b6555d0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70985-002-01 | 70985000201 | 100 TABLET in 1 BOTTLE (70985-002-01) | 100 tablet | 2016-11-08 | 0000-00-00 | No | No | Current |
| 70985-002-02 | 70985000202 | 500 TABLET in 1 BOTTLE (70985-002-02) | 500 tablet | 2016-11-08 | 0000-00-00 | No | No | Current |
| 70985-002-03 | 70985000203 | 30 TABLET in 1 BOTTLE (70985-002-03) | 30 tablet | 2021-08-05 | 0000-00-00 | No | No | Current |
| 70985-002-04 | 70985000204 | 90 TABLET in 1 BOTTLE (70985-002-04) | 90 tablet | 2021-08-05 | 0000-00-00 | No | No | Current |
| 70985-002-05 | 70985000205 | 300 TABLET in 1 BOTTLE (70985-002-05) | 300 tablet | 2021-08-05 | 0000-00-00 | No | No | Current |