Loratadine
- Product NDC
- 53329-651
- 11-digit product format
- 533290651
- Labeler code
- 53329
- Product ID
- 53329-651_8012abf1-23da-4d42-8fb2-b6def38c1c74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medline Industries, Inc.
- Application
- ANDA076134
- Marketing category
- ANDA
- Marketing start
- 2003-08-19
- Marketing end
- 0000-00-00
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53329-651-33 | Loratadine | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 53329-651-38 | Loratadine | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53329-651 | LORATADINE TABLET [MEDLINE INDUSTRIES, INC.] | 1 | Legacy NDC, 2 package rows | 20130326_7a3d416e-ccbe-4823-9c76-ee5b2001599e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53329-651-33 | 53329065133 | 30 in 1 BOTTLE | Historical |
| 53329-651-38 | 53329065138 | 90 in 1 BOTTLE | Historical |