Over-the-counter drug · ANDA
Childrens Allergy (Fexofenadine hydrochloride) NDC 61269-527
Fexofenadine hydrochloride 30 mg/5mL · Suspension · Oral · H2-Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-527-94 | 6126905279461269052794 | 1 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLEMarketed from Jul 18, 2022 |
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)
- Childrens Allergy
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 30 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- H2-Pharma, LLCNDC labeler code 61269
- 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 61269-527_67f3284f-3041-44b7-9daf-ec9e87fd6701SPL ID 67f3284f-3041-44b7-9daf-ec9e87fd6701SPL set ID 84988f6d-85b1-45dd-89be-0333acc6b180RxCUI 997491UNII 2S068B75ZU
- 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
N461269052794followed by a unit qualifier and the quantityPackage 61269-0527-94. 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 itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 61269-527
- What is NDC 61269-527?
- 61269-527 is the product NDC for Childrens Allergy (fexofenadine hydrochloride), Fexofenadine hydrochloride 30 mg/5mL suspension, listed with the FDA by H2-Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Allergy (Fexofenadine hydrochloride).
- What is the active ingredient?
- Fexofenadine hydrochloride.
- Who is the labeler?
- H2-Pharma, LLC, NDC labeler code 61269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Allergy?
- 25 other product NDCs are listed under this name. See all Childrens Allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens 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) |
|---|---|---|---|---|---|
| Childrens Allergyfluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-197 | 51316-0197-08 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | WALMART INC. (see also Equate) | 79903-249 | 79903-0249-04 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | CVS PHARMACY, INC | 51316-260 | 51316-0260-04 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | Family Dollar (FAMILY WELLNESS) | 55319-923 | 55319-0923-04 |
| Childrens Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | KinderFarms, LLC | 82673-109 | 82673-0109-04 |
| Childrens Allergydiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Genexa Inc. | 69676-0074 | 69676-0074-09 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | H E B | 37808-623 | 37808-0623-04 |
| Childrens Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | AptaPharma Inc. | 76281-505 | 76281-0505-24 |
| Childrens Allergyfexofenadine hcl | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-208 | 49035-0208-04 |
| childrens allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Kroger Company | 30142-651 | 30142-0651-2630142-0651-34 |
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 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 |