Cetirizine Hydrochloride
- Product NDC
- 69206-990
- 11-digit product format
- 692060990
- Labeler code
- 69206
- Product ID
- 69206-990_3e808491-ec96-4f20-bb5e-3a9e5c72550e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Aventura Pharmaceuticals, LLC
- Application
- ANDA078876
- Marketing category
- ANDA
- Marketing start
- 2023-02-01
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69206-990-01 | Cetirizine Hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69206-990 | CETIRIZINE HYDROCHLORIDE SOLUTION [AVENTURA PHARMACEUTICALS, LLC] | 2 | Current NDC, 1 package rows | 20241011_aeb73ab9-3b05-4062-a7fd-352cf2094a56.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69206-990-01 | 69206099001 | 120 mL in 1 BOTTLE (69206-990-01) | 120 ml | 2023-02-01 | No | No | Current |