Loratadine
- Product NDC
- 0378-8880
- 11-digit product format
- 003788880
- Labeler code
- 0378
- Product ID
- 0378-8880_1392dd15-842c-4689-87ba-caafc0503bca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA076154
- Marketing category
- ANDA
- Marketing start
- 2011-06-01
- 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 |
|---|
| 0378-8880-10 | Loratadine | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8880 | LORATADINE TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20190205_3b307aea-5a68-4c82-959a-cda4ffbd0a4a.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 |
|---|
| 0378-8880-10 | 00378888010 | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-8880-10) | 1000 tablet | 2011-06-01 | 0000-00-00 | No | No | Current |