Fexofenadine hydrochloride
- Product NDC
- 55111-783
- 11-digit product format
- 551110783
- Labeler code
- 55111
- Product ID
- 55111-783_9c0b82c6-7eff-3eec-40e2-db72a8625eff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA076502
- Marketing category
- ANDA
- Marketing start
- 2011-01-03
- 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, 997488, 997501 |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-783 | FEXOFENADINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED] | 19 | Current NDC, Legacy NDC | 20250508_864e3052-5787-bf11-9d17-11274ca2304f.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 |
|---|
| 55111-783-01 | 55111078301 | 100 TABLET in 1 BOTTLE (55111-783-01) | 100 tablet | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-783-24 | 55111078324 | 4 BLISTER PACK in 1 CARTON (55111-783-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2020-12-01 | 0000-00-00 | No | No | Current |
| 55111-783-28 | 55111078328 | 2 BLISTER PACK in 1 CARTON (55111-783-28) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2020-12-01 | 0000-00-00 | No | No | Current |
| 55111-783-30 | 55111078330 | 30 TABLET in 1 BOTTLE (55111-783-30) | 30 tablet | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-783-60 | 55111078360 | 60 TABLET in 1 BOTTLE (55111-783-60) | 60 tablet | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-783-78 | 55111078378 | 10 BLISTER PACK in 1 CARTON (55111-783-78) / 10 TABLET in 1 BLISTER PACK (55111-783-79) | 10 blister pack | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-783-90 | 55111078390 | 90 TABLET in 1 BOTTLE (55111-783-90) | 90 tablet | 2011-01-03 | 0000-00-00 | No | No | Current |
| 55111-783-94 | 55111078394 | 4000 TABLET in 1 POUCH (55111-783-94) | 4000 tablet | 14-OCT-20 | | | | Current |