Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 30142-059
- 11-digit product format
- 301420059
- Labeler code
- 30142
- Product ID
- 30142-059_9902b6fe-db86-4b16-9302-c194c98aa97e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- KROGER COMPANY
- Application
- ANDA209116
- Marketing category
- ANDA
- Marketing start
- 2021-03-15
- 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 |
|---|
| 30142-059-20 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 4 |
| 30142-059-20 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | | 4 |
| 30142-059-84 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 3 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 3 | | 4 |
| 30142-059-84 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 30142-059 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [KROGER COMPANY] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240613_b8b2c45d-3aba-d98a-e053-2a95a90a879b.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 |
|---|
| 30142-059-20 | 30142005920 | 2 BLISTER PACK in 1 CARTON (30142-059-20) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2024-05-18 | | No | No | Current |
| 30142-059-84 | 30142005984 | 3 BLISTER PACK in 1 CARTON (30142-059-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2021-03-15 | 0000-00-00 | No | No | Current |