Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Product NDC
- 51660-037
- 11-digit product format
- 516600037
- Labeler code
- 51660
- Product ID
- 51660-037_437a9779-39c2-6e34-e063-6294a90a55bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ohm Laboratories Inc.
- Application
- ANDA090818
- Marketing category
- ANDA
- Marketing start
- 2018-03-01
- 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 |
|---|
| 51660-037-21 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
| 51660-037-21 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 20 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 20 | | 3 |
| 51660-037-31 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 3 |
| 51660-037-31 | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51660-037 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [OHM LABORATORIES INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20231215_87ab4578-84de-475d-a4b0-eec969f17253.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 |
|---|
| 51660-037-21 | 51660003721 | 1 BLISTER PACK in 1 CARTON (51660-037-21) / 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |
| 51660-037-31 | 51660003731 | 1 BLISTER PACK in 1 CARTON (51660-037-31) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2018-03-01 | 0000-00-00 | No | No | Current |