Over-the-counter drug · ANDA
leader childrens allergy relief (Loratadine) NDC 70000-0473
Loratadine 5 mg/5mL · Solution · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0473-1 | 7000004730170000047301 | 1 BOTTLE in 1 CARTON (70000-0473-1) / 120 mL in 1 BOTTLEMarketed from Jan 23, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- leader childrens allergy relief
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075728
- Marketing start
- Listing expires
- Identifiers
- Product ID 70000-0473_dcec05fa-b447-436b-ac94-01c75b950693SPL ID dcec05fa-b447-436b-ac94-01c75b950693SPL set ID 20b438e1-f461-48fa-b007-4c02ecb91b68RxCUI 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
N470000047301followed by a unit qualifier and the quantityPackage 70000-0473-01. 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 70000-0473
- What is NDC 70000-0473?
- 70000-0473 is the product NDC for leader childrens allergy relief (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- leader childrens allergy relief (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for leader childrens allergy relief?
- 1 other product NDC are listed under this name. See all leader childrens allergy relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other leader childrens allergy relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| leader childrens allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Cardinal Health 110, LLC. dba Leader | 70000-0474 | 70000-0474-01 |
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 |
| 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 Loratadine Oralloratadine | Loratadine 5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6767 |
| 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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