Loratadine
- Product NDC
- 49035-953
- 11-digit product format
- 490350953
- Labeler code
- 49035
- Product ID
- 49035-953_0ea6cbb4-1105-fecf-e063-6394a90a513b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Wal-Mart Stores, Inc
- Application
- ANDA210088
- Marketing category
- ANDA
- Marketing start
- 2018-05-01
- 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 |
|---|
| 49035-953-30 | Loratadine | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | | 3 |
| 49035-953-30 | Loratadine | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49035-953 | LORATADINE TABLET, CHEWABLE [WAL-MART STORES, INC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240112_f62c48ab-8dd3-4ed1-a123-d478efe8e839.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 |
|---|
| 49035-953-30 | 49035095330 | 3 BLISTER PACK in 1 CARTON (49035-953-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 3 blister pack | 2018-05-01 | 0000-00-00 | No | No | Current |