Childrens Allergy
- Product NDC
- 51316-260
- 11-digit product format
- 513160260
- Labeler code
- 51316
- Product ID
- 51316-260_efb68be9-99c9-4254-a8fa-daae8eb75f28
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- Application
- ANDA203330
- Marketing category
- ANDA
- Marketing start
- 2023-10-15
- Marketing end
- 2026-12-28
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 30 mg/5mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Allergy
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEXOFENADINE HYDROCHLORIDE | 30 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU |
| Rxcui | 997491 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-260-04 | Childrens Allergy | 1 in 1 BOX | SUSPENSION | 1 | | 3 |
| 51316-260-04 | Childrens Allergy | 118 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 118 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-260 | CHILDRENS ALLERGY (FEXOFENADINE HCL) SUSPENSION [CVS PHARMACY, INC] | 2 | Current NDC, 2 package rows | 20240314_4ab89e0a-d5aa-481b-8793-c940a27ebeb2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51316-260-04 | 51316026004 | 1 BOTTLE, PLASTIC in 1 BOX (51316-260-04) / 118 mL in 1 BOTTLE, PLASTIC | 2023-10-15 | 2026-12-28 | No | No | Historical |