Fexofenadine HCl
- Product NDC
- 69230-201
- 11-digit product format
- 692300201
- Labeler code
- 69230
- Product ID
- 69230-201_09845f21-f05e-34b2-e063-6394a90a7677
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Consumer Care
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2021-12-08
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEXOFENADINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU |
| Rxcui | 997420, 997501 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69230-201-01 | Fexofenadine HCl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 69230-201-05 | Fexofenadine HCl | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69230-201 | FEXOFENADINE HCL TABLET, FILM COATED [CAMBER CONSUMER CARE] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231108_1bb1bea3-b17d-4326-b037-7468add0df80.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69230-201-01 | 69230020101 | 100 TABLET, FILM COATED in 1 BOTTLE (69230-201-01) | 2021-12-08 | | No | No | Current |
| 69230-201-05 | 69230020105 | 500 TABLET, FILM COATED in 1 BOTTLE (69230-201-05) | 2021-12-08 | 0000-00-00 | No | No | Current |