levocetirizine dihydrochloride
- Product NDC
- 63868-473
- 11-digit product format
- 638680473
- Labeler code
- 63868
- Product ID
- 63868-473_62bd5a02-2f4d-697f-856c-7516352417c1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association INC
- Application
- ANDA210375
- Marketing category
- ANDA
- Marketing start
- 2020-06-24
- 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 |
|---|
| 63868-473-35 | levocetirizine dihydrochloride | 35 in 1 BOTTLE | TABLET, COATED | 35 | | 3 |
| 63868-473-35 | levocetirizine dihydrochloride | 1 in 1 CARTON | TABLET, COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-473 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20231014_61fb8bef-d868-adee-3237-d3268d603ba6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63868-473-35 | 63868047335 | 1 BOTTLE in 1 CARTON (63868-473-35) / 35 TABLET, COATED in 1 BOTTLE | 1 bottle | 2020-06-24 | 0000-00-00 | No | No | Current |