Claritin-D
- Product NDC
- 11523-0102
- 11-digit product format
- 115230102
- Labeler code
- 11523
- Product ID
- 11523-0102_4526d9ef-02fb-338e-e063-6394a90af108
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine pseudoephedrine sulfate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- ANDA075706
- Marketing category
- ANDA
- Marketing start
- 2022-12-12
- Substance
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 10; 240 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 7AJO3BO7QN | LORATADINE | 79794-75-5 | LORATADINE |
| Y9DL7QPE6B | PSEUDOEPHEDRINE SULFATE | 7460-12-0 | PSEUDOEPHEDRINE SULFATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 11523-0102-1 | 11523010201 | 1 BLISTER PACK in 1 CARTON (11523-0102-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2022-12-12 | No | No | Historical |
| 11523-0102-2 | 11523010202 | 1 BLISTER PACK in 1 CARTON (11523-0102-2) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2022-12-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Claritin-D ® 24 Hour | Bayer HealthCare LLC. | 2025-12-04 | HUMAN OTC DRUG LABEL | 9 |