LEVOCETIRIZINE DIHYDROCHLORIDE
- Product NDC
- 71335-0418
- 11-digit product format
- 713350418
- Labeler code
- 71335
- Product ID
- 71335-0418_30c06d79-0809-46a9-a520-2f92cbeb4797
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOCETIRIZINE DIHYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205564
- Marketing category
- ANDA
- Marketing start
- 2016-01-11
- 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 |
|---|
| 71335-0418-1 | LEVOCETIRIZINE DIHYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 71335-0418-2 | LEVOCETIRIZINE DIHYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
| 71335-0418-3 | LEVOCETIRIZINE DIHYDROCHLORIDE | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 8 |
| 71335-0418-4 | LEVOCETIRIZINE DIHYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0418 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 7 | Current NDC, Legacy NDC, 4 package rows | 20230331_1b593c65-2866-45d9-9c94-ac181f4cbc51.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 |
|---|
| 71335-0418-1 | 71335041801 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0418-1) | 2017-08-30 | 0000-00-00 | No | No | Current |
| 71335-0418-2 | 71335041802 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0418-2) | 2017-08-30 | 0000-00-00 | No | No | Current |
| 71335-0418-3 | 71335041803 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-0418-3) | 2017-08-30 | 0000-00-00 | No | No | Current |
| 71335-0418-4 | 71335041804 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0418-4) | 2017-08-30 | 0000-00-00 | No | No | Current |