Levocetirizine Dihydrochloride
- Product NDC
- 72789-023
- 11-digit product format
- 727890023
- Labeler code
- 72789
- Product ID
- 72789-023_2d58a1fb-47b6-e4c8-e063-6294a90ad5f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA091264
- Marketing category
- ANDA
- Marketing start
- 2012-06-29
- 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 |
|---|
| 72789-023-30 | Levocetirizine Dihydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-023 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20250206_57c7c673-790c-4158-87ca-7d8fb68c4286.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 |
|---|
| 72789-023-30 | 72789002330 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-023-30) | 30 tablet | 2019-10-17 | 0000-00-00 | No | No | Current |