Loratadine
- Product NDC
- 17856-0557
- 11-digit product format
- 178560557
- Labeler code
- 17856
- Product ID
- 17856-0557_4bc0edf7-fe2e-d8ab-e063-6394a90a8886
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA077421
- Marketing category
- ANDA
- Marketing start
- 2019-02-13
- Substance
- LORATADINE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN |
| Rxcui | 692783 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17856-0557-1 | Loratadine | 72 in 1 BOX, UNIT-DOSE | SOLUTION | 72 | | 5 |
| 17856-0557-2 | Loratadine | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0557 | LORATADINE SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250514_999a1080-5bbd-4027-b6e7-a90a6941ee27.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 |
|---|
| 17856-0557-1 | 17856055701 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0557-1) > 5 mL in 1 CUP, UNIT-DOSE | | 2021-01-22 | 0000-00-00 | No | No | Current |
| 17856-0557-2 | 17856055702 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |