Loratadine and Pseudoephedrine Sulfate
- Product NDC
- 36800-724
- 11-digit product format
- 368000724
- Labeler code
- 36800
- Product ID
- 36800-724_71a4c639-174f-4480-91c1-033eb90b85f7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine and Pseudoephedrine Sulfate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA076557
- Marketing category
- ANDA
- Marketing start
- 2004-11-17
- Marketing end
- 0000-00-00
- Substance
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 10 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-724-15 | Loratadine and Pseudoephedrine Sulfate | 15 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 15 | | 1 |
| 36800-724-69 | Loratadine and Pseudoephedrine Sulfate | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 1 |
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 [TOPCO ASSOCIATES LLC] | 1 | |
| PSEUDOEPHEDRINE SULFATE | ACTIVE INGREDIENT | Y9DL7QPE6B | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-724 | LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 1 | Legacy NDC, 2 package rows | 20130110_d2b77078-5124-443e-a6db-5860170f7a13.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 36800-724-15 | 36800072415 | 15 in 1 BLISTER PACK | Historical |
| 36800-724-69 | 36800072469 | 10 in 1 BLISTER PACK | Historical |