levocetirizine dihydrochloride
- Product NDC
- 71335-0940
- 11-digit product format
- 713350940
- Labeler code
- 71335
- Product ID
- 71335-0940_c56f1c2a-3e1a-4e1a-9b6c-855351030d80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levocetirizine dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203646
- Marketing category
- ANDA
- Marketing start
- 2014-10-27
- 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 |
|---|
| 71335-0940-1 | levocetirizine dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 71335-0940-2 | levocetirizine dihydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 71335-0940-3 | levocetirizine dihydrochloride | 28 in 1 BOTTLE | TABLET | 28 | | 3 |
| 71335-0940-4 | levocetirizine dihydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0940 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 3 | Current NDC, Legacy NDC, 4 package rows | 20190612_34541530-ae3b-4247-b08c-cd1c13e2e6a1.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 |
|---|
| 71335-0940-1 | 71335094001 | 30 TABLET in 1 BOTTLE (71335-0940-1) | 30 tablet | 2018-08-30 | 0000-00-00 | No | No | Current |
| 71335-0940-2 | 71335094002 | 90 TABLET in 1 BOTTLE (71335-0940-2) | 90 tablet | 2018-08-30 | 0000-00-00 | No | No | Current |
| 71335-0940-3 | 71335094003 | 28 TABLET in 1 BOTTLE (71335-0940-3) | 28 tablet | 2018-08-30 | 0000-00-00 | No | No | Current |
| 71335-0940-4 | 71335094004 | 60 TABLET in 1 BOTTLE (71335-0940-4) | 60 tablet | 2018-08-30 | 0000-00-00 | No | No | Current |