CLARINEX-D 12 HOUR
- Product NDC
- 78206-120
- 11-digit product format
- 782060120
- Labeler code
- 78206
- Product ID
- 78206-120_64c0d4d8-2434-45c4-801e-710026c5b07f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- desloratadine and pseudoephedrine sulfate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Organon LLC
- Application
- NDA021313
- Marketing category
- NDA
- Marketing start
- 2021-06-01
- Substance
- DESLORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 2.5; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CLARINEX-D 12 HOUR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DESLORATADINE | 2.5 mg/1 |
| PSEUDOEPHEDRINE SULFATE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FVF865388R, Y9DL7QPE6B |
| Rxcui | 1112248, 1112250 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78206-120-01 | CLARINEX-D 12 HOUR | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78206-120 | CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [ORGANON LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241201_1af66b7a-4ab8-40d8-abdd-22d3310228a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 78206-120-01 | 78206012001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01) | 2021-06-01 | 0000-00-00 | No | No | Current |