Cetirizine
- Product NDC
- 55154-0194
- 11-digit product format
- 551540194
- Labeler code
- 55154
- Product ID
- 55154-0194_597b2e28-63a6-41b6-9914-b4eb9965ffab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA078336
- Marketing category
- ANDA
- Marketing start
- 2025-11-07
- 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
- 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 |
|---|
| 55154-0194-0 | Cetirizine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 3 |
| 55154-0194-0 | Cetirizine | 10 in 1 BAG | TABLET, FILM COATED | 10 | | 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 |
|---|
| 55154-0194-0 | 55154019400 | 10 BLISTER PACK in 1 BAG (55154-0194-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2025-11-07 | No | No | Historical |