Fexofenadine Hydrochloride
- Product NDC
- 51655-231
- 11-digit product format
- 516550231
- Labeler code
- 51655
- Product ID
- 51655-231_48d2c7f6-8550-1b9c-e063-6394a90ada4e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2022-11-16
- Marketing end
- 2026-10-28
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fexofenadine Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEXOFENADINE HYDROCHLORIDE | 180 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU |
| Rxcui | 997420 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-231-26 | Fexofenadine Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 2 |
| 51655-231-52 | Fexofenadine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-231 | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HCL) TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 2 package rows | 20230301_f2b6c157-1af1-8d43-e053-2995a90aaf1a.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 |
|---|
| 51655-231-26 | 51655023126 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-231-26) | 90 tablet | 2022-12-08 | 2026-10-28 | No | No | Historical |
| 51655-231-52 | 51655023152 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-231-52) | 30 tablet | 2022-11-16 | 2026-10-28 | No | No | Historical |