Levocetirizine Dihydrochloride
- Product NDC
- 53217-375
- 11-digit product format
- 532170375
- Labeler code
- 53217
- Product ID
- 53217-375_345afcc5-23ac-4174-be4e-97a724db622d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA203027
- Marketing category
- ANDA
- Marketing start
- 2018-04-17
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-375-30 | Levocetirizine Dihydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-375 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20180823_1efcf912-1187-4d69-895c-30d363e5eb7a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-375-30 | 53217037530 | 30 in 1 BOTTLE | Historical |