Cetirizine Hydrochloride
- Product NDC
- 0378-3635
- 11-digit product format
- 003783635
- Labeler code
- 0378
- Product ID
- 0378-3635_5670c6c3-a4ab-4268-917a-99e0579f3079
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cetirizine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076677
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014676, 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-3635-01 | Cetirizine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-3635 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20220113_487ae0f0-320c-4534-b9e2-0e215f167cea.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 |
|---|
| 0378-3635-01 | 00378363501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3635-01) | 2007-12-27 | 0000-00-00 | No | No | Current |