levocetirizine dihydrochloride
- Product NDC
- 43598-810
- 11-digit product format
- 435980810
- Labeler code
- 43598
- Product ID
- 43598-810_ea46c444-7f75-7cd9-4030-3a59be54ccdc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA210375
- Marketing category
- ANDA
- Marketing start
- 2018-12-26
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-810 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [DR. REDDY'S LABORATORIES INC.] | 2 | Current NDC, Legacy NDC | 20231014_fb0a3619-9d5b-5c58-82f3-31f031672f33.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 |
|---|
| 43598-810-76 | 43598081076 | 2 BOTTLE in 1 CARTON (43598-810-76) / 80 TABLET, COATED in 1 BOTTLE | 2 bottle | 2018-12-26 | 0000-00-00 | No | No | Current |
| 43598-810-80 | 43598081080 | 1 BOTTLE in 1 CARTON (43598-810-80) / 80 TABLET, COATED in 1 BOTTLE | 1 bottle | 2018-12-26 | 0000-00-00 | No | No | Current |