CETIRIZINE HYDROCHLORIDE
- Product NDC
- 61037-480
- 11-digit product format
- 610370480
- Labeler code
- 61037
- Product ID
- 61037-480_3ba3f1a6-e1ea-f193-e063-6394a90ad645
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- BAJAJ MEDICAL, LLC
- Application
- ANDA091327
- Marketing category
- ANDA
- Marketing start
- 2025-05-08
- 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 |
|---|
| 61037-480-02 | CETIRIZINE HYDROCHLORIDE | 120 mL in 1 BOTTLE, PLASTIC | SOLUTION | 120 | | 3 |
| 61037-480-03 | CETIRIZINE HYDROCHLORIDE | 480 mL in 1 BOTTLE, PLASTIC | SOLUTION | 480 | | 3 |
| 61037-480-04 | CETIRIZINE HYDROCHLORIDE | 240 mL in 1 BOTTLE, PLASTIC | SOLUTION | 240 | | 3 |
| 61037-480-06 | CETIRIZINE HYDROCHLORIDE | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 3 |
| 61037-480-12 | CETIRIZINE HYDROCHLORIDE | 5 mL in 1 BOX, UNIT-DOSE | SOLUTION | 5 | | 3 |
| 61037-480-22 | CETIRIZINE HYDROCHLORIDE | 120 mL in 1 BOTTLE, PLASTIC | SOLUTION | 120 | | 3 |
| 61037-480-23 | CETIRIZINE HYDROCHLORIDE | 480 mL in 1 BOTTLE, PLASTIC | SOLUTION | 480 | | 3 |
| 61037-480-24 | CETIRIZINE HYDROCHLORIDE | 240 mL in 1 BOTTLE, PLASTIC | SOLUTION | 240 | | 3 |
| 61037-480-26 | CETIRIZINE HYDROCHLORIDE | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 3 |
| 61037-480-32 | CETIRIZINE HYDROCHLORIDE | 5 mL in 1 BOX, UNIT-DOSE | SOLUTION | 5 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 61037-480-02 | 61037048002 | 120 mL in 1 BOTTLE, PLASTIC (61037-480-02) | 120 ml | 2025-05-08 | No | No | Historical |
| 61037-480-03 | 61037048003 | 480 mL in 1 BOTTLE, PLASTIC (61037-480-03) | 480 ml | 2025-05-08 | No | No | Historical |
| 61037-480-04 | 61037048004 | 240 mL in 1 BOTTLE, PLASTIC (61037-480-04) | 240 ml | 2025-05-08 | No | No | Historical |
| 61037-480-06 | 61037048006 | 5 mL in 1 CUP, UNIT-DOSE (61037-480-06) | 5 ml | 2025-05-08 | No | No | Historical |
| 61037-480-12 | 61037048012 | 5 mL in 1 BOX, UNIT-DOSE (61037-480-12) | 5 ml | 2025-05-08 | No | No | Historical |
| 61037-480-22 | 61037048022 | 120 mL in 1 BOTTLE, PLASTIC (61037-480-22) | 120 ml | 2025-05-08 | No | No | Historical |
| 61037-480-23 | 61037048023 | 480 mL in 1 BOTTLE, PLASTIC (61037-480-23) | 480 ml | 2025-05-08 | No | No | Historical |
| 61037-480-24 | 61037048024 | 240 mL in 1 BOTTLE, PLASTIC (61037-480-24) | 240 ml | 2025-05-08 | No | No | Historical |
| 61037-480-26 | 61037048026 | 5 mL in 1 CUP, UNIT-DOSE (61037-480-26) | 5 ml | 2025-05-08 | No | No | Historical |
| 61037-480-32 | 61037048032 | 5 mL in 1 BOX, UNIT-DOSE (61037-480-32) | 5 ml | 2025-05-08 | No | No | Historical |