Cetirizine Hydrochloride
- Product NDC
- 47335-343
- 11-digit product format
- 473350343
- Labeler code
- 47335
- Product ID
- 47335-343_650b77fc-76c9-4ab9-a671-d72f6def4c42
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090142
- Marketing category
- ANDA
- Marketing start
- 2011-09-09
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014643, 1014674 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-343-83 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 12 |
| 47335-343-88 | Cetirizine Hydrochloride | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| GUAR GUM | INACTIVE INGREDIENT | E89I1637KE | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| MAGNESIUM OXIDE | INACTIVE INGREDIENT | 3A3U0GI71G | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-343 | CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240920_a4758152-97dd-4a27-b4d9-11178654b93e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-343-15 | 47335034315 | 30 TABLET, CHEWABLE in 1 BOTTLE (47335-343-15) | 2011-09-26 | 0000-00-00 | No | No | Current |
| 47335-343-16 | 47335034316 | 100 TABLET, CHEWABLE in 1 BOTTLE (47335-343-16) | 2011-09-26 | 0000-00-00 | No | No | Current |
| 47335-343-83 | 47335034383 | 30 TABLET, CHEWABLE in 1 BOTTLE (47335-343-83) | 2011-09-09 | 0000-00-00 | No | No | Current |
| 47335-343-88 | 47335034388 | 100 TABLET, CHEWABLE in 1 BOTTLE (47335-343-88) | 2011-09-09 | 0000-00-00 | No | No | Current |