Fexofenadine HCl and Pseudoephedrine HCI
- Product NDC
- 55111-447
- 11-digit product format
- 551110447
- Labeler code
- 55111
- Product ID
- 55111-447_2624a9e0-c674-dcc0-472d-888f41fc0436
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl and Pseudoephedrine HCI
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA076667
- Marketing category
- ANDA
- Marketing start
- 2014-11-18
- Substance
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 60; 120 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- Fexofenadine HCl and Pseudoephedrine HCI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEXOFENADINE HYDROCHLORIDE | 60 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU, 6V9V2RYJ8N |
| Rxcui | 997406 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-447-07 | Fexofenadine HCl and Pseudoephedrine HCI | 5 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 5 | | 7 |
| 55111-447-14 | Fexofenadine HCl and Pseudoephedrine HCI | 4 in 1 CARTON | TABLET, EXTENDED RELEASE | 4 | | 7 |
| 55111-447-31 | Fexofenadine HCl and Pseudoephedrine HCI | 6 in 1 CARTON | TABLET, EXTENDED RELEASE | 6 | | 7 |
| 55111-447-35 | Fexofenadine HCl and Pseudoephedrine HCI | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FEXOFENADINE HYDROCHLORIDE | ACTIVE INGREDIENT | 2S068B75ZU | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| FEXOFENADINE | ACTIVE MOIETY | E6582LOH6V | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-447 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | Current NDC, Legacy NDC, 4 package rows | 20241222_728632be-7e5c-2d06-4c95-bc8ecc9be2ec.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 |
|---|
| 55111-447-07 | 55111044707 | 5 in 1 BLISTER PACK | | | | | | Historical |
| 55111-447-14 | 55111044714 | 4 BLISTER PACK in 1 CARTON (55111-447-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07) | 4 blister pack | 2014-11-18 | 0000-00-00 | No | No | Current |
| 55111-447-31 | 55111044731 | 6 BLISTER PACK in 1 CARTON (55111-447-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07) | 6 blister pack | 2014-11-18 | 0000-00-00 | No | No | Current |
| 55111-447-35 | 55111044735 | 2 BLISTER PACK in 1 CARTON (55111-447-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-447-07) | 2 blister pack | 2014-11-18 | 0000-00-00 | No | No | Current |