Fexofenadine Hydrochloride
- Product NDC
- 62207-765
- 11-digit product format
- 622070765
- Labeler code
- 62207
- Product ID
- 62207-765_3b98f58b-cf16-dcd8-e063-6394a90a8b01
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules India Ltd
- Application
- ANDA211075
- Marketing category
- ANDA
- Marketing start
- 2020-12-18
- 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
- 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 |
|---|
| 62207-765-49 | Fexofenadine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
| 62207-765-51 | Fexofenadine Hydrochloride | 1 in 1 CARTON | TABLET | 1 | | 7 |
| 62207-765-51 | Fexofenadine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 7 |
| 62207-765-60 | Fexofenadine Hydrochloride | 8 in 1 CARTON | TABLET | 8 | | 7 |
| 62207-765-60 | Fexofenadine Hydrochloride | 9 in 1 BLISTER PACK | TABLET | 9 | | 7 |
| 62207-765-88 | Fexofenadine Hydrochloride | 5 in 1 BOX | TABLET | 5 | | 7 |
| 62207-765-88 | Fexofenadine Hydrochloride | 10000 in 1 POUCH | TABLET | 10000 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-765 | FEXOFENADINE HYDROCHLORIDE TABLET [GRANULES INDIA LTD] | 6 | Current NDC, Legacy NDC, 7 package rows | 20230131_3151bc6d-b40b-4200-a5cf-e57b6791d92a.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 |
|---|
| 62207-765-49 | 62207076549 | 1000 TABLET in 1 BOTTLE (62207-765-49) | 1000 tablet | 2020-12-18 | 0000-00-00 | No | No | Current |
| 62207-765-51 | 62207076551 | 1 BOTTLE in 1 CARTON (62207-765-51) / 10 TABLET in 1 BOTTLE | 1 bottle | 2020-12-18 | 0000-00-00 | No | No | Current |
| 62207-765-60 | 62207076560 | 8 BLISTER PACK in 1 CARTON (62207-765-60) / 9 TABLET in 1 BLISTER PACK | 8 blister pack | 2020-12-18 | 0000-00-00 | No | No | Current |
| 62207-765-88 | 62207076588 | 5 POUCH in 1 BOX (62207-765-88) / 10000 TABLET in 1 POUCH | 5 pouch | 2021-11-17 | 0000-00-00 | No | No | Current |