Fexofenadine Hydrochloride
- Product NDC
- 73629-008
- 11-digit product format
- 736290008
- Labeler code
- 73629
- Product ID
- 73629-008_47d41023-701b-09eb-e063-6294a90a7298
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AMZ789 LLC
- Application
- ANDA211075
- Marketing category
- ANDA
- Marketing start
- 2024-07-27
- 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 |
|---|
| 73629-008-03 | Fexofenadine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73629-008 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [AMZ789 LLC] | 1 | Current NDC, 1 package rows | 20240830_1e46343f-d6b6-73ba-e063-6394a90acd94.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 73629-008-03 | 73629000803 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73629-008-03) | 2024-07-27 | No | No | Historical |