Over-the-counter drug · ANDA
Dye Free Wal Fex childrens allergy (Fexofenadine hcl) NDC 0363-9230
Fexofenadine hydrochloride 30 mg/5mL · Suspension · Oral · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-9230-04 | 0036392300400363923004 | 1 BOTTLE, PLASTIC in 1 BOX (0363-9230-04) / 118 mL in 1 BOTTLE, PLASTICMarketed from Jun 1, 2020 | |
| 0363-9230-08 | 0036392300800363923008 | 1 BOTTLE, PLASTIC in 1 BOX (0363-9230-08) / 237 mL in 1 BOTTLE, PLASTICMarketed from Jun 1, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Dye Free Wal Fex childrens allergySuffix: childrens allergy
- Generic name (nonproprietary)
- fexofenadine hcl
- Active ingredients
- Fexofenadine hydrochloride — 30 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- WalgreensNDC labeler code 0363
- 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 0363-9230_97aafbd4-7cc5-43f3-82cb-8799f8360862SPL ID 97aafbd4-7cc5-43f3-82cb-8799f8360862SPL set ID 9062c258-4c3e-412d-a31f-1e748a67513fRxCUI 997491, 1670344UNII 2S068B75ZUUPC 0311917212319
- 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
N400363923004followed by a unit qualifier and the quantityPackage 00363-9230-04. 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 0363-9230
- What is NDC 0363-9230?
- 0363-9230 is the product NDC for Dye Free Wal Fex childrens allergy, Fexofenadine hydrochloride 30 mg/5mL suspension, listed with the FDA by Walgreens. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dye Free Wal Fex childrens allergy (Fexofenadine HCL).
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- Walgreens, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dye Free Wal Fex childrens allergy?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| Children Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | H E B | 37808-654 |
| 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 |