Loratadine and Pseudoephedrine Sulfate
- Product NDC
- 0904-5833
- 11-digit product format
- 009045833
- Labeler code
- 0904
- Product ID
- 0904-5833_3e4ab498-9f9e-bd3b-e063-6294a90a9b9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine and Pseudoephedrine Sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loratadine and Pseudoephedrine Sulfate
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-5833-15 | Loratadine and Pseudoephedrine Sulfate | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 5 |
| 0904-5833-48 | Loratadine and Pseudoephedrine Sulfate | 15 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 15 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| PSEUDOEPHEDRINE SULFATE | ACTIVE INGREDIENT | Y9DL7QPE6B | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-5833 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241106_2620a150-4a2c-4fa2-a0e4-6aafe9e496c3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-5833-15 | 00904583315 | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5833-15) | 2004-11-17 | 0000-00-00 | No | No | Current |
| 0904-5833-48 | 00904583348 | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0904-5833-48) | 2004-11-17 | 0000-00-00 | No | No | Current |