Fexofenadine Hydrochloride
- Product NDC
- 62207-889
- 11-digit product format
- 622070889
- Labeler code
- 62207
- Product ID
- 62207-889_44f30c29-5caf-7d3c-e063-6394a90a7d36
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Granules India Limited
- Application
- ANDA211075
- Marketing category
- ANDA
- Marketing start
- 2023-11-07
- 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 Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEXOFENADINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62207-889-49 | Fexofenadine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 62207-889-51 | Fexofenadine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
| 62207-889-51 | Fexofenadine Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 3 |
| 62207-889-60 | Fexofenadine Hydrochloride | 8 in 1 CARTON | TABLET, FILM COATED | 8 | | 3 |
| 62207-889-60 | Fexofenadine Hydrochloride | 9 in 1 BLISTER PACK | TABLET, FILM COATED | 9 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-889 | FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [GRANULES INDIA LIMITED] | 2 | Current NDC, 5 package rows | 20231114_e0537b71-fdee-4122-9c09-868ce7352080.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62207-889-49 | 62207088949 | 1000 TABLET, FILM COATED in 1 BOTTLE (62207-889-49) | | 2023-11-07 | No | No | Current |
| 62207-889-51 | 62207088951 | 1 BOTTLE in 1 CARTON (62207-889-51) / 10 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2023-11-07 | No | No | Current |
| 62207-889-60 | 62207088960 | 8 BLISTER PACK in 1 CARTON (62207-889-60) / 9 TABLET, FILM COATED in 1 BLISTER PACK | 8 blister pack | 2023-11-07 | No | No | Current |