Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 41415-995
- 11-digit product format
- 414150995
- Labeler code
- 41415
- Product ID
- 41415-995_aac48a0b-2b28-4c14-9baa-84c08713e6c2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hydrochloride and pseudoephedrine hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PUBLIX SUPER MARKETS, INC
- Application
- ANDA090818
- Marketing category
- ANDA
- Marketing start
- 2021-11-08
- 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 |
|---|
| 41415-995-20 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 20 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 20 | | 3 |
| 41415-995-20 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 3 |
| 41415-995-30 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 3 |
| 41415-995-30 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41415-995 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PUBLIX SUPER MARKETS, INC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20241016_75236b23-af51-40b6-ad1b-f62a27093a16.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 |
|---|
| 41415-995-20 | 41415099520 | 1 BLISTER PACK in 1 CARTON (41415-995-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-11-08 | 0000-00-00 | No | No | Current |
| 41415-995-30 | 41415099530 | 1 BLISTER PACK in 1 CARTON (41415-995-30) / 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-11-08 | 0000-00-00 | No | No | Current |