Over-the-counter drug · ANDA
Childrens Allergy (Loratadine) NDC 49035-538
Loratadine 5 mg/5mL · Solution · Oral · Wal-Mart Stores Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49035-538-08 | 4903505380849035053808 | 1 BOTTLE in 1 CARTON (49035-538-08) / 120 mL in 1 BOTTLEMarketed from Jun 21, 2019 | |
| 49035-538-09 | 4903505380949035053809 | 1 BOTTLE in 1 CARTON (49035-538-09) / 120 mL in 1 BOTTLEMarketed from Mar 7, 2021 |
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)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Wal-Mart Stores IncNDC labeler code 49035
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201865
- Marketing start
- Listing expires
- Identifiers
- Product ID 49035-538_6ee5b7e9-711d-4d18-9cea-09a4d19d4332SPL ID 6ee5b7e9-711d-4d18-9cea-09a4d19d4332SPL set ID 9fb3a3a8-8812-4238-b596-291b79085db9RxCUI 692783UNII 7AJO3BO7QN
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
N449035053808followed by a unit qualifier and the quantityPackage 49035-0538-08. 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 49035-538
- What is NDC 49035-538?
- 49035-538 is the product NDC for Childrens Allergy (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Wal-Mart Stores Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Allergy (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Wal-Mart Stores Inc, NDC labeler code 49035. 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 Allergyfexofenadine hydrochloride | Fexofenadine hydrochloride 30 mg/5mL | SuspensionOral | H2-Pharma, LLC | 61269-527 | 61269-0527-94 |
| 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 |
Other NDCs under ANDA 201865
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 |
|---|---|---|---|---|
| Childrens Allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | CVS Pharmacy | 69842-535 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2108 |
| Childrens Walitinloratadine | Loratadine 5 mg/5mL | SolutionOral | Walgreen Company | 0363-2108 |
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | WALGREEN COMPANY | 0363-0771 |