Cetirizine Hydrochloride
- Product NDC
- 16571-401
- 11-digit product format
- 165710401
- Labeler code
- 16571
- Product ID
- 16571-401_37fb3dd8-d5bf-46e4-8331-0c8c1eac540d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- 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 |
|---|
| 16571-401-10 | Cetirizine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-401 | CETIRIZINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240319_6493d4f6-dead-45ec-ade1-28ce624af33d.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 |
|---|
| 16571-401-10 | 16571040110 | 100 TABLET in 1 BOTTLE (16571-401-10) | 100 tablet | 2009-10-01 | 0000-00-00 | No | No | Current |