FEXOFENADINE HYDROCHLORIDE
- Product NDC
- 68210-0122
- 11-digit product format
- 682100122
- Labeler code
- 68210
- Product ID
- 68210-0122_ee27ea1a-c047-9030-e053-2995a90a131e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FEXOFENADINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- ANDA210137
- Marketing category
- ANDA
- Marketing start
- 2019-03-21
- Marketing end
- 0000-00-00
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-0122-1 | FEXOFENADINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 68210-0122-3 | FEXOFENADINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 68210-0122-3 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-0122 | FEXOFENADINE HYDROCHLORIDE TABLET [SPIRIT PHARMACEUTICALS LLC] | 8 | Legacy NDC, 3 package rows | 20241215_c18f3207-92ad-4999-99c8-b51a1edcece3.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 |
|---|
| 68210-0122-1 | 68210012201 | 100 TABLET in 1 BOTTLE (68210-0122-1) | 100 tablet | 2019-03-22 | 0000-00-00 | No | No | Current |
| 68210-0122-3 | 68210012203 | 1 BOTTLE in 1 CARTON (68210-0122-3) > 30 TABLET in 1 BOTTLE | 1 bottle | 2020-09-18 | 0000-00-00 | No | No | Current |