Fexofenadine Hydrochloride
- Product NDC
- 68554-5063
- 11-digit product format
- 685545063
- Labeler code
- 68554
- Product ID
- 68554-5063_12c87ec8-6af5-41bf-931a-8937e63cbad4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hetero Labs Limited
- Application
- ANDA204097
- Marketing category
- ANDA
- Marketing start
- 2016-08-23
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68554-5063-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a4d4-f424-e053-dadaa90a57ce | Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg |
| 68554-5063-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a4d4-f424-e053-dadaa90a57ce | Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg |
| 68554-5063-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a4d4-f424-e053-dadaa90a57ce | Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg |
| 68554-5063-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a4d4-f424-e053-dadaa90a57ce | Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg |
| 68554-5063-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a4d4-f424-e053-dadaa90a57ce | Fexofenadine Hydrochloride Tablets USP, 30 mg, 60 mg and 180 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68554-5063-0 | Fexofenadine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 68554-5063-0 | Fexofenadine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 68554-5063-1 | Fexofenadine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 68554-5063-1 | Fexofenadine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 68554-5063-2 | Fexofenadine Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 68554-5063-2 | Fexofenadine Hydrochloride | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
| 68554-5063-3 | Fexofenadine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
| 68554-5063-4 | Fexofenadine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
| 68554-5063-5 | Fexofenadine Hydrochloride | 7 in 1 CARTON | TABLET, FILM COATED | 7 | | 2 |
| 68554-5063-6 | Fexofenadine Hydrochloride | 15 in 1 CARTON | TABLET, FILM COATED | 15 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68554-5063 | FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [HETERO LABS LIMITED] | 2 | Legacy NDC, 10 package rows | 20160909_412af925-12e9-405f-b3c3-d5c3d0b5d5c2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68554-5063-0 | 68554506300 | 30 in 1 BOTTLE | Historical |
| 68554-5063-1 | 68554506301 | 100 in 1 BOTTLE | Historical |
| 68554-5063-2 | 68554506302 | 500 in 1 BOTTLE | Historical |
| 68554-5063-3 | 68554506303 | 10 in 1 BLISTER PACK | Historical |
| 68554-5063-4 | 68554506304 | 10 in 1 BLISTER PACK | Historical |
| 68554-5063-5 | 68554506305 | 7 in 1 CARTON | Historical |
| 68554-5063-6 | 68554506306 | 15 in 1 CARTON | Historical |