fexofenadine hcl
- Product NDC
- 77771-202
- 11-digit product format
- 777710202
- Labeler code
- 77771
- Product ID
- 77771-202_302845c7-2356-3b13-e063-6394a90a0e26
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine hcl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Radha Pharmaceuticals
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2025-03-10
- 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
- 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 | 180 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 |
|---|
| 77771-202-01 | fexofenadine hcl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 77771-202-05 | fexofenadine hcl | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 77771-202-30 | fexofenadine hcl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 77771-202 | FEXOFENADINE HCL TABLET, FILM COATED [RADHA PHARMACEUTICALS] | 1 | Current NDC, 3 package rows | 20250315_30283df1-6394-3a91-e063-6394a90a6776.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 77771-202-01 | 77771020201 | 100 TABLET, FILM COATED in 1 BOTTLE (77771-202-01) | 2025-03-10 | No | No | Current |
| 77771-202-05 | 77771020205 | 500 TABLET, FILM COATED in 1 BOTTLE (77771-202-05) | 2025-03-10 | No | No | Current |
| 77771-202-30 | 77771020230 | 30 TABLET, FILM COATED in 1 BOTTLE (77771-202-30) | 2025-03-10 | No | No | Current |