Levocetirizine Dihydrochloride
- Product NDC
- 71205-476
- 11-digit product format
- 712050476
- Labeler code
- 71205
- Product ID
- 71205-476_c2d5fe36-08b4-46cc-b6d9-8663f57d56d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levocetirizine Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA203646
- Marketing category
- ANDA
- Marketing start
- 2019-09-19
- 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 |
|---|
| 71205-476-30 | Levocetirizine Dihydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
| 71205-476-60 | Levocetirizine Dihydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 2 |
| 71205-476-90 | Levocetirizine Dihydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-476 | LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [PROFICIENT RX LP] | 2 | Current NDC, Legacy NDC, 3 package rows | 20221029_7108ad0a-af1e-4172-b4ba-e5d9aaadfba7.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 |
|---|
| 71205-476-30 | 71205047630 | 30 TABLET in 1 BOTTLE, PLASTIC (71205-476-30) | 30 tablet | 2020-09-23 | 0000-00-00 | No | No | Current |
| 71205-476-60 | 71205047660 | 60 TABLET in 1 BOTTLE, PLASTIC (71205-476-60) | 60 tablet | 2020-09-23 | 0000-00-00 | No | No | Current |
| 71205-476-90 | 71205047690 | 90 TABLET in 1 BOTTLE, PLASTIC (71205-476-90) | 90 tablet | 2020-09-23 | 0000-00-00 | No | No | Current |