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
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 |
|---|
| 11523-0102-1 | Claritin-D24 Hour | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 9 |
| 11523-0102-1 | Claritin-D24 Hour | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 9 |
| 11523-0102-2 | Claritin-D24 Hour | 15 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 15 | | 9 |
| 11523-0102-2 | Claritin-D24 Hour | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Loratadine | ACTIVE INGREDIENT | 7AJO3BO7QN | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| pseudoephedrine sulfate | ACTIVE INGREDIENT | Y9DL7QPE6B | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| Loratadine | ACTIVE MOIETY | 7AJO3BO7QN | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| pseudoephedrine | ACTIVE MOIETY | 7CUC9DDI9F | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| calcium phosphate, dibasic, dihydrate | INACTIVE INGREDIENT | O7TSZ97GEP | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| ethylcelluloses | INACTIVE INGREDIENT | 7Z8S9VYZ4B | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| hydroxypropyl cellulose (type h) | INACTIVE INGREDIENT | RFW2ET671P | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | CLARITIN-D 24 HOUR (LORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [MSD CONSUMER CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11523-0102 | CLARITIN-D 24 HOUR (LORATADINE PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20231201_3ea6a90b-8cb1-46b0-9ff7-be7090245e53.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 |
|---|
| 11523-0102-1 | 11523010201 | 1 BLISTER PACK in 1 CARTON (11523-0102-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2022-12-12 | 0000-00-00 | No | No | Current |
| 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 | 0000-00-00 | No | No | Current |