Claritin-D
- Product NDC
- 11523-4332
- 11-digit product format
- 115234332
- Labeler code
- 11523
- Product ID
- 11523-4332_45370575-1a5d-c6f1-e063-6394a90a24c4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine and pseudoephedrine sulfate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- NDA020470
- Marketing category
- NDA
- Marketing start
- 2009-12-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Claritin-D
- Brand name suffix
- 24 Hour
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 10 mg/1 |
| PSEUDOEPHEDRINE SULFATE | 240 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN, Y9DL7QPE6B |
| Rxcui | 1117562, 1242391 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11523-4332-1 | Claritin-D24 Hour | 5 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 5 | | 11 |
| 11523-4332-1 | Claritin-D24 Hour | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 11 |
| 11523-4332-2 | Claritin-D24 Hour | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 11 |
| 11523-4332-2 | Claritin-D24 Hour | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 11 |
| 11523-4332-3 | Claritin-D24 Hour | 5 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 5 | | 11 |
| 11523-4332-3 | Claritin-D24 Hour | 3 in 1 CARTON | TABLET, EXTENDED RELEASE | 3 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11523-4332 | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.] | 10 | Current NDC, Legacy NDC, 6 package rows | 20241208_f046a807-ab8c-0620-e053-2a95a90a9d3c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11523-4332-1 | 11523433201 | 1 BLISTER PACK in 1 CARTON (11523-4332-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2009-12-01 | 0000-00-00 | No | No | Current |
| 11523-4332-2 | 11523433202 | 1 BLISTER PACK in 1 CARTON (11523-4332-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2009-12-01 | 0000-00-00 | No | No | Current |
| 11523-4332-3 | 11523433203 | 3 BLISTER PACK in 1 CARTON (11523-4332-3) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2009-12-01 | 0000-00-00 | No | No | Current |