Loratadine
- Product NDC
- 57243-200
- 11-digit product format
- 572430200
- Labeler code
- 57243
- Product ID
- 57243-200_9874d1db-f339-49f9-8225-ca61c05f1d64
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- McLane Company, Inc.
- Application
- ANDA208314
- Marketing category
- ANDA
- Marketing start
- 2018-04-16
- 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 |
|---|
| 57243-200-69 | Loratadine | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 57243-200-69 | 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 |
|---|
| 57243-200 | LORATADINE TABLET [MCLANE COMPANY, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221105_f988f9fb-463d-4aaa-b83d-54a3b114e570.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 |
|---|
| 57243-200-69 | 57243020069 | 1 BLISTER PACK in 1 CARTON (57243-200-69) / 10 TABLET in 1 BLISTER PACK | 1 blister pack | 2018-04-16 | 0000-00-00 | No | No | Current |