Desloratadine
- Product NDC
- 69339-194
- 11-digit product format
- 693390194
- Labeler code
- 69339
- Product ID
- 69339-194_e4db30a5-48e5-4fe3-8793-30b6866f87c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desloratadine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Natco Pharma USA LLC
- Application
- ANDA078351
- Marketing category
- ANDA
- Marketing start
- 2026-04-01
- Substance
- DESLORATADINE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Desloratadine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DESLORATADINE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FVF865388R |
| Rxcui | 349420 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69339-194-01 | Desloratadine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 69339-194-05 | Desloratadine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69339-194-01 | 69339019401 | 100 TABLET, FILM COATED in 1 BOTTLE (69339-194-01) | 2026-04-01 | No | No | Current |
| 69339-194-05 | 69339019405 | 500 TABLET, FILM COATED in 1 BOTTLE (69339-194-05) | 2026-04-01 | No | No | Current |