Allervarx
- Product NDC
- 57483-950
- 11-digit product format
- 574830950
- Labeler code
- 57483
- Product ID
- 57483-950_d91b9ee4-dbd2-459c-a789-a59b7bf61d0e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Innovus Pharmaceuticals, Inc.
- Application
- ANDA213294
- Marketing category
- ANDA
- Marketing start
- 2022-05-30
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Allervarx
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 311373 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57483-950-10 | Allervarx | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | | 3 |
| 57483-950-10 | Allervarx | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57483-950 | ALLERVARX (LORATADINE) TABLET, ORALLY DISINTEGRATING [INNOVUS PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241228_885e81ae-5ea3-4d14-8666-8c2698767014.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 |
|---|
| 57483-950-10 | 57483095010 | 3 BLISTER PACK in 1 CARTON (57483-950-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2022-05-30 | 0000-00-00 | No | No | Current |