Children Allergy
- Product NDC
- 37808-654
- 11-digit product format
- 378080654
- Labeler code
- 37808
- Product ID
- 37808-654_24026246-18c5-41b2-b760-b2552505292e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCL
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- H E B
- Application
- ANDA203330
- Marketing category
- ANDA
- Marketing start
- 2023-10-31
- 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
- Children 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 |
|---|
| 37808-654-04 | Children Allergy | 118 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 118 | | 3 |
| 37808-654-04 | Children Allergy | 1 in 1 BOX | SUSPENSION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37808-654 | CHILDREN ALLERGY (FEXOFENADINE HCL) SUSPENSION [H E B] | 2 | Current NDC, 2 package rows | 20240426_a26c3515-4a24-4988-b9bb-813420b15630.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 |
|---|
| 37808-654-04 | 37808065404 | 1 BOTTLE, PLASTIC in 1 BOX (37808-654-04) / 118 mL in 1 BOTTLE, PLASTIC | 2023-10-31 | 2026-12-28 | No | No | Historical |