Loratadine
- Product NDC
- 72789-380
- 11-digit product format
- 727890380
- Labeler code
- 72789
- Product ID
- 72789-380_4bc0370f-21d9-1acb-e063-6394a90ad768
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2008-10-15
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine
- Brand name suffix
- antihistamine
- Listing expiration
- 2027-12-31
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 |
|---|
| 72789-380-15 | Loratadineantihistamine | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-380 | LORATADINE ANTIHISTAMINE (LORATADINE) TABLET [PD-RX PHARMACEUTICALS, INC.] | 9 | Current NDC, 1 package rows | 20250406_775885f9-0580-4eca-94d8-44fce1dcdccd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-380-15 | 72789038015 | 15 TABLET in 1 BOTTLE, PLASTIC (72789-380-15) | 15 tablet | 2024-02-07 | No | No | Historical |