Loratadine
- Product NDC
- 0363-9985
- 11-digit product format
- 003639985
- Labeler code
- 0363
- Product ID
- 0363-9985_275123ff-399a-9195-e063-6294a90af2b4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- WALGREENS CO.
- Application
- ANDA210088
- Marketing category
- ANDA
- Marketing start
- 2020-08-01
- Substance
- LORATADINE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 665078 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0363-9985-30 | Loratadine | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | | 4 |
| 0363-9985-30 | Loratadine | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | | 4 |
| 0363-9985-60 | Loratadine | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | | 4 |
| 0363-9985-60 | Loratadine | 6 in 1 CARTON | TABLET, CHEWABLE | 6 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-9985 | LORATADINE TABLET, CHEWABLE [WALGREENS CO.] | 4 | Current NDC, 4 package rows | 20241121_c9e12155-a699-4fa7-aac8-da7d5ddab4ae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0363-9985-30 | 00363998530 | 3 BLISTER PACK in 1 CARTON (0363-9985-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 3 blister pack | 2024-03-15 | No | No | Current |
| 0363-9985-60 | 00363998560 | 6 BLISTER PACK in 1 CARTON (0363-9985-60) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 6 blister pack | 2024-03-15 | No | No | Current |