Cetirizine Hydrochloride
- Product NDC
- 71205-093
- 11-digit product format
- 712050093
- Labeler code
- 71205
- Product ID
- 71205-093_26beeb96-f0b4-4e99-ba9d-3b27c67659dc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077829
- Marketing category
- ANDA
- Marketing start
- 2009-10-01
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014676 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71205-093-15 | Cetirizine Hydrochloride | 15 in 1 BOTTLE | TABLET | 15 | | 3 |
| 71205-093-30 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 71205-093-60 | Cetirizine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 71205-093-90 | Cetirizine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-093 | CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 4 package rows | 20191029_9c2b97d9-9990-46ab-9027-c34ffb07ce8f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-093-15 | 71205009315 | 15 TABLET in 1 BOTTLE (71205-093-15) | 15 tablet | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-093-30 | 71205009330 | 30 TABLET in 1 BOTTLE (71205-093-30) | 30 tablet | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-093-60 | 71205009360 | 60 TABLET in 1 BOTTLE (71205-093-60) | 60 tablet | 2018-08-01 | 0000-00-00 | No | No | Current |
| 71205-093-90 | 71205009390 | 90 TABLET in 1 BOTTLE (71205-093-90) | 90 tablet | 2018-08-01 | 0000-00-00 | No | No | Current |