Cetirizine Hydrochloride
- Product NDC
- 63187-110
- 11-digit product format
- 631870110
- Labeler code
- 63187
- Product ID
- 63187-110_c091c3f5-1961-49ad-b4d5-b82062d31e88
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-110-30 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 63187-110-60 | Cetirizine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 63187-110-90 | Cetirizine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-110 | CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 3 package rows | 20220622_d14feb90-3ca2-4d5b-825c-25fc2252ca38.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 |
|---|
| 63187-110-30 | 63187011030 | 30 TABLET in 1 BOTTLE (63187-110-30) | 30 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-110-60 | 63187011060 | 60 TABLET in 1 BOTTLE (63187-110-60) | 60 tablet | 2021-07-09 | 0000-00-00 | No | No | Current |
| 63187-110-90 | 63187011090 | 90 TABLET in 1 BOTTLE (63187-110-90) | 90 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |