Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 79903-108
- 11-digit product format
- 799030108
- Labeler code
- 79903
- Product ID
- 79903-108_63e13a01-14d7-f9e0-7e48-bbe87e99783d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Wal-mart Stores, Inc.
- Application
- ANDA215434
- Marketing category
- ANDA
- Marketing start
- 2022-03-31
- 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 |
|---|
| 79903-108 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WAL-MART STORES, INC.] | 6 | Current NDC, Legacy NDC | 20230523_a0ce5002-08e3-c21f-9b88-f3dd27dc9dda.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 |
|---|
| 79903-108-20 | 79903010820 | 4 BLISTER PACK in 1 CARTON (79903-108-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 4 blister pack | 2023-03-17 | 0000-00-00 | No | No | Current |
| 79903-108-30 | 79903010830 | 6 BLISTER PACK in 1 CARTON (79903-108-30) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 6 blister pack | 2023-03-17 | 0000-00-00 | No | No | Current |