Loratadine and Pseudoephedrine
- Product NDC
- 85766-048
- 11-digit product format
- 857660048
- Labeler code
- 85766
- Product ID
- 85766-048_4a2c2629-df77-dec0-e063-6394a90a45a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine and pseudoephedrine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA076557
- Marketing category
- ANDA
- Marketing start
- 2004-11-17
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine and Pseudoephedrine
- Listing expiration
- 2027-12-31
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-048-10 | Loratadine and Pseudoephedrine | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 2 |
| 85766-048-10 | Loratadine and Pseudoephedrine | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-048-10 | 85766004810 | 1 BLISTER PACK in 1 CARTON (85766-048-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2025-08-02 | No | No | Historical |