FEXOFENADINE HYDROCHLORIDE
- Product NDC
- 51660-998
- 11-digit product format
- 516600998
- Labeler code
- 51660
- Product ID
- 51660-998_5110b287-1464-50d9-e063-6394a90abe0f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FEXOFENADINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- OHM LABORATORIES INC.
- Application
- ANDA091567
- Marketing category
- ANDA
- Marketing start
- 2022-04-29
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FEXOFENADINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51660-998-30 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 51660-998-30 | FEXOFENADINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 51660-998-55 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 51660-998-55 | FEXOFENADINE HYDROCHLORIDE | 150 in 1 BOTTLE | TABLET, FILM COATED | 150 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51660-998 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [OHM LABORATORIES INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20220503_1a1afa95-570d-456e-b436-a0fcfaf68517.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 |
|---|
| 51660-998-30 | 51660099830 | 1 BOTTLE in 1 CARTON (51660-998-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-04-29 | 0000-00-00 | No | No | Current |
| 51660-998-55 | 51660099855 | 1 BOTTLE in 1 CARTON (51660-998-55) / 150 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-04-29 | 0000-00-00 | No | No | Current |