Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 37808-999
- 11-digit product format
- 378080999
- Labeler code
- 37808
- Product ID
- 37808-999_1f6d54d4-f124-4194-b6dc-b9e37fd54faa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- H E B
- Application
- ANDA090818
- Marketing category
- ANDA
- Marketing start
- 2018-08-01
- 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 Hydrochloride and Pseudoephedrine Hydrochloride
- 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 |
|---|
| 37808-999-30 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 1 |
| 37808-999-30 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37808-999 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H E B] | 1 | Current NDC, Legacy NDC, 2 package rows | 20180801_5167ab78-f898-47ec-8baf-843269469d10.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 |
|---|
| 37808-999-30 | 37808099930 | 1 BLISTER PACK in 1 CARTON (37808-999-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2018-08-01 | 0000-00-00 | No | No | Current |