Desloratadine
- Product NDC
- 69452-363
- 11-digit product format
- 694520363
- Labeler code
- 69452
- Product ID
- 69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desloratadine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA078357
- Marketing category
- ANDA
- Marketing start
- 2023-11-28
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Desloratadine
- Listing expiration
- 2026-12-31
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 |
|---|
| 69452-363-20 | Desloratadine | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
| 69452-363-30 | Desloratadine | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-363 | DESLORATADINE TABLET, FILM COATED [BIONPHARMA INC.] | 1 | Current NDC, 2 package rows | 20231128_4d094001-b85a-47b3-bc67-a46660384ece.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69452-363-20 | 69452036320 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20) | 2023-11-28 | No | No | Historical |
| 69452-363-30 | 69452036330 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30) | 2023-11-28 | No | No | Historical |