Fexofenadine HCl and Pseudoephedrine HCI
- Product NDC
- 21130-557
- 11-digit product format
- 211300557
- Labeler code
- 21130
- Product ID
- 21130-557_dfda3c7c-4c57-5917-ab77-7b5372ec14d2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl and Pseudoephedrine HCI
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Safeway Inc
- Application
- ANDA079043
- Marketing category
- ANDA
- Marketing start
- 2013-02-05
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 180 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 |
|---|
| 21130-557-35 | Fexofenadine HCl and Pseudoephedrine HCI | 5 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 5 | | 1 |
| 21130-557-35 | Fexofenadine HCl and Pseudoephedrine HCI | 2 in 1 CARTON | TABLET, EXTENDED RELEASE | 2 | | 1 |
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 [SAFEWAY INC] | 1 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| FEXOFENADINE | ACTIVE MOIETY | E6582LOH6V | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| ACETYLTRIBUTYL CITRATE | INACTIVE INGREDIENT | 0ZBX0N59RZ | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| COPOVIDONE | INACTIVE INGREDIENT | D9C330MD8B | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21130-557 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [SAFEWAY INC] | 1 | Legacy NDC, 2 package rows | 20140218_65a92250-d0e8-c902-b14c-67f53ab26635.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21130-557-35 | 21130055735 | 5 in 1 BLISTER PACK | Historical |