Fexofenadine Hydrochloride
- Product NDC
- 0378-0781
- 11-digit product format
- 003780781
- Labeler code
- 0378
- Product ID
- 0378-0781_f35905cb-7f58-41f1-a851-403032789d14
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fexofenadine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA077081
- Marketing category
- ANDA
- Marketing start
- 2011-08-25
- Marketing end
- 2022-02-28
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0781-05 | 00378078105 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-05) | 2011-08-25 | 0000-00-00 | No | No | Current |
| 0378-0781-91 | 00378078191 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-91) | 2011-08-25 | 2022-02-28 | No | No | Current |