Fexofenadine hydrochloride
- Product NDC
- 0363-0783
- 11-digit product format
- 003630783
- Labeler code
- 0363
- Product ID
- 0363-0783_99bc952b-03e9-cb28-9669-ce7dfef79b0d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Walgreens Company
- Application
- ANDA076502
- Marketing category
- ANDA
- Marketing start
- 2020-12-14
- 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 |
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 |
|---|
| 0363-0783-24 | Fexofenadine hydrochloride | 6 in 1 BLISTER PACK | TABLET | 6 | | 4 |
| 0363-0783-24 | Fexofenadine hydrochloride | 4 in 1 CARTON | TABLET | 4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-0783 | FEXOFENADINE HYDROCHLORIDE TABLET [WALGREENS COMPANY] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240730_b961985e-0c18-b36f-d82e-32ff2d46fada.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0363-0783-24 | 00363078324 | 4 BLISTER PACK in 1 CARTON (0363-0783-24) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2020-12-14 | 0000-00-00 | No | No | Current |