Levocetirizine Dihydrochloride
- Product NDC
- 33261-947
- 11-digit product format
- 332610947
- Labeler code
- 33261
- Product ID
- 33261-947_803c7ca1-ccca-4d6f-9365-d0c26530700a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA090362
- Marketing category
- ANDA
- Marketing start
- 2013-02-05
- Marketing end
- 0000-00-00
- Substance
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33261-947-30 | Levocetirizine Dihydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | ACTIVE INGREDIENT | SOD6A38AGA | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LEVOCETIRIZINE | ACTIVE MOIETY | 6U5EA9RT2O | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-947 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20140110_c5c62893-186d-4d1a-b900-52558b171dd7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-947-30 | 33261094730 | 30 in 1 BOTTLE, PLASTIC | Historical |