Over-the-counter drug · ANDA
Childrens Loratadine Oral (Loratadine) NDC 0904-6767
Loratadine 5 mg/5mL · Solution · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6767-20 | 0090467672000904676720 | 1 BOTTLE in 1 CARTON (0904-6767-20) / 120 mL in 1 BOTTLEMarketed from Feb 12, 2019 |
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)
- Childrens Loratadine Oral
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075728
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-6767_efdb406d-9562-4ed6-b461-683c82e26a73SPL ID efdb406d-9562-4ed6-b461-683c82e26a73SPL set ID 3f0f0131-b516-4ff3-8049-3d3766324b66RxCUI 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
N400904676720followed by a unit qualifier and the quantityPackage 00904-6767-20. 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 0904-6767
- What is NDC 0904-6767?
- 0904-6767 is the product NDC for Childrens Loratadine Oral (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Loratadine Oral (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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 Loratadine Oral?
- 2 other product NDCs are listed under this name. See all Childrens Loratadine Oral NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Loratadine Oral 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 Loratadine Oralloratadine | Loratadine 5 mg/5mL | SolutionOral | Atlantic Biologicals | 17856-6767 | 17856-6767-01 |
| Childrens Loratadine Oralloratadine | Loratadine 5 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-7516 | 50090-7516-00 |
Other NDCs under ANDA 075728
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 allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Meijer, Inc. | 41250-716 |
| Good Sense childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8657 |
| Good Sense childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | L. Perrigo Company | 0113-0671 |
| Childrens Loratadine Oralloratadine | Loratadine 5 mg/5mL | SolutionOral | Atlantic Biologicals | 17856-6767 |
| Childrens Allergy Reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-611 |
| good neighbor pharmacy childrens loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | Amerisource Bergen | 46122-787 |
| leader childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Cardinal Health 110, LLC. dba Leader | 70000-0473 |
| equate childrens allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Wal-Mart Stores Inc | 49035-611 |
| topcare childrens allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Topco Associates LLC | 36800-608 |
| Childrens Allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | CVS Pharmacy | 69842-337 |
| childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Kroger Company | 30142-723 |
| Up And Up Childrens Allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Target Corporation | 82442-207 |
| childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Rite Aid Corporation | 11822-0620 |
| Good Sense childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | NuCare Pharmaceuticals,Inc. | 68071-3904 |
| Equaline Childrens Allergy Reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-633 |
| good sense childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | L. Perrigo Company | 0113-1719 |
| basic care childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-511 |
| welby childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Aldi Inc | 64024-023 |
| childrens allergy reliefloratadine | Loratadine 5 mg/5mL | SolutionOral | Amazon.com Services LLC | 72288-533 |
| dg health childrens allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Dolgencorp, LLC | 55910-611 |
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