Cetirizine
- Product NDC
- 83939-0003
- 11-digit product format
- 839390003
- Labeler code
- 83939
- Product ID
- 83939-0003_43f4168a-615f-a724-e063-6394a90a24b6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- VERITYRX, LLC
- Application
- ANDA078336
- Marketing category
- ANDA
- Marketing start
- 2025-11-03
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine
- Listing expiration
- 2026-12-31
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 |
|---|
| 83939-0003-0 | Cetirizine | 50 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 50 | | 1 |
| 83939-0003-0 | Cetirizine | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 1 |
| 83939-0003-2 | Cetirizine | 50 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 50 | | 1 |
| 83939-0003-2 | Cetirizine | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 1 |
| 83939-0003-3 | Cetirizine | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 1 |
| 83939-0003-3 | Cetirizine | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83939-0003-0 | 83939000300 | 50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-0) / 1 TABLET, FILM COATED in 1 POUCH | 50 pouch | 2025-11-03 | No | No | Historical |
| 83939-0003-2 | 83939000302 | 50 POUCH in 1 BOX, UNIT-DOSE (83939-0003-2) / 1 TABLET, FILM COATED in 1 POUCH | 50 pouch | 2025-11-03 | No | No | Historical |
| 83939-0003-3 | 83939000303 | 100 POUCH in 1 BOX, UNIT-DOSE (83939-0003-3) / 1 TABLET, FILM COATED in 1 POUCH | 100 pouch | 2025-11-03 | No | No | Historical |