Loratadine
- Product NDC
- 70000-0583
- 11-digit product format
- 700000583
- Labeler code
- 70000
- Product ID
- 70000-0583_57c1fc35-94df-4613-bfec-97f1dd995df0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health
- Application
- ANDA208314
- Marketing category
- ANDA
- Marketing start
- 2021-08-30
- 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
- Loratadine
- 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 | 311372 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0583-1 | Loratadine | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 70000-0583-1 | Loratadine | 2 in 1 CARTON | TABLET | 2 | | 4 |
| 70000-0583-2 | Loratadine | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 70000-0583-2 | Loratadine | 1 in 1 CARTON | TABLET | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0583 | LORATADINE TABLET [CARDINAL HEALTH] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240619_c96dd1c9-85a0-0792-e053-2a95a90a2264.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 |
|---|
| 70000-0583-1 | 70000058301 | 2 BLISTER PACK in 1 CARTON (70000-0583-1) / 10 TABLET in 1 BLISTER PACK | 2 blister pack | 2021-08-30 | 0000-00-00 | No | No | Current |
| 70000-0583-2 | 70000058302 | 1 BOTTLE in 1 CARTON (70000-0583-2) / 30 TABLET in 1 BOTTLE | 1 bottle | 2024-06-14 | | No | No | Current |