Levocetirizine Dihydrochloride
- Product NDC
- 85786-206
- 11-digit product format
- 857860206
- Labeler code
- 85786
- Product ID
- 85786-206_4ed17484-560a-d993-e063-6294a90a82a2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Farmacias De Similares TX LLC
- Application
- ANDA213513
- Marketing category
- ANDA
- Marketing start
- 2026-04-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levocetirizine Dihydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 85786-206-30 | Levocetirizine Dihydrochloride | 15 in 1 BLISTER PACK | TABLET, FILM COATED | 15 | | 1 |
| 85786-206-30 | Levocetirizine Dihydrochloride | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85786-206-30 | 85786020630 | 2 BLISTER PACK in 1 CARTON (85786-206-30) / 15 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2026-04-06 | No | No | Current |