Fexofenadine HCl and Pseudoephedrine HCI
- Product NDC
- 37808-022
- 11-digit product format
- 378080022
- Labeler code
- 37808
- Product ID
- 37808-022_8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl and Pseudoephedrine HCI
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- HEB
- Application
- ANDA076667
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- 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 |
|---|
| 37808-022-31 | Fexofenadine HCl and Pseudoephedrine HCI | 6 in 1 CARTON | TABLET, EXTENDED RELEASE | 6 | | 3 |
| 37808-022-31 | Fexofenadine HCl and Pseudoephedrine HCI | 5 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37808-022 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [HEB] | 3 | Current NDC, Legacy NDC, 2 package rows | 20171208_0de7fc37-7f46-4e98-d5ac-d31a3c313a62.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 |
|---|
| 37808-022-31 | 37808002231 | 6 BLISTER PACK in 1 CARTON (37808-022-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 6 blister pack | 2015-12-21 | 0000-00-00 | No | No | Current |