Over-the-counter drug · ANDA
Children Allergy (Fexofenadine hcl) NDC 37808-654
Fexofenadine hydrochloride 30 mg/5mL · Suspension · Oral · H E B
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-654-04 | 3780806540437808065404 | 1 BOTTLE, PLASTIC in 1 BOX (37808-654-04) / 118 mL in 1 BOTTLE, PLASTICMarketed from Oct 31, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Children Allergy
- Generic name (nonproprietary)
- fexofenadine hcl
- Active ingredients
- Fexofenadine hydrochloride — 30 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- H E BNDC labeler code 37808
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203330
- Marketing start
- Marketing end
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 37808-654_24026246-18c5-41b2-b760-b2552505292eSPL ID 24026246-18c5-41b2-b760-b2552505292eSPL set ID a26c3515-4a24-4988-b9bb-813420b15630RxCUI 997491UNII 2S068B75ZUUPC 0041220221820
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N437808065404followed by a unit qualifier and the quantityPackage 37808-0654-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 37808-654
- What is NDC 37808-654?
- 37808-654 is the product NDC for Children Allergy (fexofenadine hcl), Fexofenadine hydrochloride 30 mg/5mL suspension, listed with the FDA by H E B. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Children Allergy (Fexofenadine HCL).
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- H E B, NDC labeler code 37808. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Children Allergy?
- 1 other product NDC are listed under this name. See all Children Allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Children Allergy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Children Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Walgreens | 0363-2600 | 00363-2600-0400363-2600-08 |
Other NDCs under ANDA 203330
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Children Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Walgreens | 0363-2600 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | H E B | 37808-623 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-208 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | CVS PHARMACY, INC | 51316-260 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Family Dollar (FAMILY WELLNESS) | 55319-923 |
| Childrens Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | H2-Pharma, LLC | 61269-527 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | WALMART INC. (see also Equate) | 79903-249 |
| Dye Free Wal Fex childrens allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Walgreens | 0363-9230 |