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 |
|---|---|
| LORATADINE | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 311372 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-8880-10 | Loratadine | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 6 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE TABLET [MYLAN INSTITUTIONAL INC.] | 3 | |
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE TABLET [MYLAN PHARMACEUTICALS INC.] | 3 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE TABLET [MYLAN INSTITUTIONAL INC.] | 3 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE TABLET [MYLAN PHARMACEUTICALS INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE TABLET [MYLAN INSTITUTIONAL INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE TABLET [MYLAN PHARMACEUTICALS INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE TABLET [MYLAN INSTITUTIONAL INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE TABLET [MYLAN PHARMACEUTICALS INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE TABLET [MYLAN INSTITUTIONAL INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE TABLET [MYLAN PHARMACEUTICALS INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311372 | loratadine 10 MG 24HR Oral Tablet | PSN | 1fc9ddd1-393d-4fe2-a9e0-d192df7331db | 11 |
| 311372 | loratadine 10 MG Oral Tablet | SCD | 1fc9ddd1-393d-4fe2-a9e0-d192df7331db | 11 |
| 311372 | loratadine 10 MG 24 HR Oral Tablet | SY | 1fc9ddd1-393d-4fe2-a9e0-d192df7331db | 11 |
| 311372 | loratadine 10 MG 24HR Oral Tablet | PSN | 3b307aea-5a68-4c82-959a-cda4ffbd0a4a | 6 |
| 311372 | loratadine 10 MG Oral Tablet | SCD | 3b307aea-5a68-4c82-959a-cda4ffbd0a4a | 6 |
| 311372 | loratadine 10 MG 24 HR Oral Tablet | SY | 3b307aea-5a68-4c82-959a-cda4ffbd0a4a | 6 |
| 311372 | loratadine 10 MG 24HR Oral Tablet | PSN | 14d1ecf5-d694-4ce0-87e4-df27f3f4d909 | 2 |
| 311372 | loratadine 10 MG Oral Tablet | SCD | 14d1ecf5-d694-4ce0-87e4-df27f3f4d909 | 2 |
| 311372 | loratadine 10 MG 24 HR Oral Tablet | SY | 14d1ecf5-d694-4ce0-87e4-df27f3f4d909 | 2 |
Packages#
| 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 |