levocetirizine dihydrochloride
- Product NDC
- 68196-406
- 11-digit product format
- 681960406
- Labeler code
- 68196
- Product ID
- 68196-406_35231680-b77b-f06e-11a5-a2107565afd1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- SAM'S WEST 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
- 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 |
|---|
| 68196-406-02 | levocetirizine dihydrochloride | 200 in 1 BOTTLE | TABLET, COATED | 200 | | 4 |
| 68196-406-20 | levocetirizine dihydrochloride | 2 in 1 CARTON | TABLET, COATED | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68196-406 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [SAM'S WEST INC ] | 2 | Current NDC, 2 package rows | 20241020_bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68196-406-02 | 68196040602 | 200 in 1 BOTTLE | | | | | Historical |
| 68196-406-20 | 68196040620 | 2 BOTTLE in 1 CARTON (68196-406-20) / 200 TABLET, COATED in 1 BOTTLE (68196-406-02) | 2 bottle | 2023-10-27 | No | No | Current |