Loratadine
- Product NDC
- 54838-554
- 11-digit product format
- 548380554
- Labeler code
- 54838
- Product ID
- 54838-554_fd40a94c-2173-4b80-a049-ab3c4faf24f4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA077421
- Marketing category
- ANDA
- Marketing start
- 2010-11-24
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 692783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54838-554-40 | Loratadine | 120 mL in 1 CARTON | SOLUTION | 120 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Loratadine | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
| Loratadine | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
| butylated hydroxyanisole | INACTIVE INGREDIENT | REK4960K2U | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | LORATADINE SOLUTION [SILARX PHARMACEUTICALS, INC] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54838-554 | LORATADINE SOLUTION [LANNETT COMPANY, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20220518_069c4e75-1f9f-4ab5-9570-3d93d12c2a23.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 |
|---|
| 54838-554-40 | 54838055440 | 120 mL in 1 CARTON (54838-554-40) | 120 ml | 2010-11-24 | 0000-00-00 | No | No | Current |