Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 51316-015
- 11-digit product format
- 513160015
- Labeler code
- 51316
- Product ID
- 51316-015_d973f66a-509e-62a5-ddbf-eb54b229ce9a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS Health Corp
- Application
- ANDA215434
- Marketing category
- ANDA
- Marketing start
- 2022-06-03
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-015 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [CVS HEALTH CORP] | 11 | Current NDC, Legacy NDC | 20230307_b009e6b1-57da-a002-1a9e-38a96cc041f1.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 |
|---|
| 51316-015-20 | 51316001520 | 4 BLISTER PACK in 1 CARTON (51316-015-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2023-03-17 | 0000-00-00 | No | No | Current |
| 51316-015-30 | 51316001530 | 6 BLISTER PACK in 1 CARTON (51316-015-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 6 blister pack | 2023-03-17 | 0000-00-00 | No | No | Current |