Levocetirizine Dihydrochloride
- Product NDC
- 43063-479
- 11-digit product format
- 430630479
- Labeler code
- 43063
- Product ID
- 43063-479_3ed97d6e-d710-dd18-e063-6294a90ac4ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090199
- Marketing category
- ANDA
- Marketing start
- 2011-09-06
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levocetirizine Dihydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOD6A38AGA |
| Rxcui | 855172 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-479-30 | Levocetirizine Dihydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | ACTIVE INGREDIENT | SOD6A38AGA | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| LEVOCETIRIZINE | ACTIVE MOIETY | 6U5EA9RT2O | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-479 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 18 | Current NDC, Legacy NDC, 1 package rows | 20241013_344ba2d6-4e17-4cef-bd7b-248fbb1af3b6.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 |
|---|
| 43063-479-30 | 43063047930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-479-30) | 2013-10-30 | 0000-00-00 | No | No | Current |