Cetirizine Hydrochloride
- Product NDC
- 0781-5284
- 11-digit product format
- 007815284
- Labeler code
- 0781
- Product ID
- 0781-5284_6b525723-7253-44e7-af75-f409b3ec77c2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA078692
- Marketing category
- ANDA
- Marketing start
- 2008-02-14
- 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 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 | 1014674 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-5284-06 | Cetirizine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 4 |
| 0781-5284-64 | Cetirizine Hydrochloride | 30 in 1 CARTON | TABLET, CHEWABLE | 30 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| BETADEX | INACTIVE INGREDIENT | JV039JZZ3A | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-5284 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241218_a814a06b-96ed-4403-bbd7-fc1142988b50.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0781-5284-06 | 00781528406 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 0781-5284-64 | 00781528464 | 30 BLISTER PACK in 1 CARTON (0781-5284-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5284-06) | 30 blister pack | 2008-02-14 | 0000-00-00 | No | No | Current |