Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 51316-007
- 11-digit product format
- 513160007
- Labeler code
- 51316
- Product ID
- 51316-007_ca6c580e-a29b-4698-a226-bb8e3bdee26b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS Pharmacy, Inc.
- Application
- ANDA209116
- Marketing category
- ANDA
- Marketing start
- 2022-11-17
- 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 |
|---|
| 51316-007-67 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | | 3 |
| 51316-007-67 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 3 |
| 51316-007-84 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 3 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 3 | | 3 |
| 51316-007-84 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-007 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240628_e9161bb2-190f-14b3-e053-2995a90a9b2f.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 |
|---|
| 51316-007-67 | 51316000767 | 2 BLISTER PACK in 1 CARTON (51316-007-67) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2022-11-17 | 0000-00-00 | No | No | Current |
| 51316-007-84 | 51316000784 | 3 BLISTER PACK in 1 CARTON (51316-007-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2022-11-17 | 0000-00-00 | No | No | Current |