loratadine D
- Product NDC
- 45802-122
- 11-digit product format
- 458020122
- Labeler code
- 45802
- Product ID
- 45802-122_64fa8aa8-ec51-4129-88d1-b1a8651061f6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine, Pseudoephedrine sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA076050
- Marketing category
- ANDA
- Marketing start
- 2018-04-10
- Substance
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 5; 120 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
- loratadine D
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORATADINE | 5 mg/1 |
| PSEUDOEPHEDRINE SULFATE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AJO3BO7QN, Y9DL7QPE6B |
| Rxcui | 1242399 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-122-46 | loratadine D | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 5 |
| 45802-122-46 | loratadine D | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 5 |
| 45802-122-60 | loratadine D | 20 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 20 | | 5 |
| 45802-122-60 | loratadine D | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 5 |
| 45802-122-65 | loratadine D | 30 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 30 | | 5 |
| 45802-122-65 | loratadine D | 1 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-122 | LORATADINE D (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 5 | Current NDC, Legacy NDC, 6 package rows | 20250321_01e61c73-3b81-4683-b1a9-8784c0d565b1.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 |
|---|
| 45802-122-46 | 45802012246 | 10 BLISTER PACK in 1 CARTON (45802-122-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2018-04-10 | 0000-00-00 | No | No | Current |
| 45802-122-60 | 45802012260 | 20 BLISTER PACK in 1 CARTON (45802-122-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 20 blister pack | 2018-04-10 | 0000-00-00 | No | No | Current |
| 45802-122-65 | 45802012265 | 30 BLISTER PACK in 1 CARTON (45802-122-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 30 blister pack | 2018-04-10 | 0000-00-00 | No | No | Current |