Cetirizine Hydrochloride
- Product NDC
- 48433-017
- 11-digit product format
- 484330017
- Labeler code
- 48433
- Product ID
- 48433-017_50c46fa3-d020-4778-e063-6394a90aed0f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cetirizine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA076677
- Marketing category
- ANDA
- Marketing start
- 2026-04-17
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 48433-017-01 | Cetirizine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 48433-017-20 | Cetirizine Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-017-01 | 48433001701 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-017-20 | 48433001720 | 100 BLISTER PACK in 1 CARTON (48433-017-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-017-01) | 100 blister pack | 2026-04-17 | No | No | Current |