Over-the-counter drug · ANDA
Loratadine NDC 70000-0125
Loratadine 5 mg/5mL · Solution · Oral · Cardinal Health, 110 dba LEADER
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0125-1 | 7000001250170000012501 | 1 BOTTLE in 1 CARTON (70000-0125-1) / 118 mL in 1 BOTTLEMarketed from Oct 24, 2016 |
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)
- Loratadine
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Cardinal Health, 110 dba LEADERNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076805
- Marketing start
- Listing expires
- Identifiers
- Product ID 70000-0125_88e1fe57-4ad1-4646-b639-e935285aec4bSPL ID 88e1fe57-4ad1-4646-b639-e935285aec4bSPL set ID db9d2182-6bf1-424a-a144-f2694c47989fRxCUI 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
N470000012501followed by a unit qualifier and the quantityPackage 70000-0125-01. 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 70000-0125
- What is NDC 70000-0125?
- 70000-0125 is the product NDC for Loratadine, Loratadine 5 mg/5mL solution, listed with the FDA by Cardinal Health, 110 dba LEADER. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine.
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Cardinal Health, 110 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 Loratadine?
- 109 other product NDCs are listed under this name. See all Loratadine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loratadine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loratadine | Loratadine 10 mg/1 | TabletOral | YYBA CORP | 73581-229 | 73581-0229-0173581-0229-03 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | AvPAK | 50268-777 | 50268-0777-01 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4103 | 68788-4103-0068788-4103-0168788-4103-03+2 more |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Safecor Health, LLC | 48433-064 | 48433-0064-20 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-119 | 84386-0119-78 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-0142 | 82725-0142-0182725-0142-0282725-0142-03+1 more |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0188 | 55154-0188-00 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7511 | 00904-7511-61 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8659 | 68788-8659-0068788-8659-0168788-8659-03+2 more |
| Loratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Tenshi Kaizen Pvt Ltd | 72983-503 | 72983-0503-06 |
Other NDCs under ANDA 076805
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 |
|---|---|---|---|---|
| Good Neighbor Pharmacy Childrens Loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | AmerisourceBergen | 24385-531 |
| Sunmark childrens loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | Strategic Sourcing Services LLC | 49348-636 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Walgreen Company | 0363-2131 |
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | STRATEGIC SOURCING SERVICES LLC | 70677-1057 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | STRATEGIC SOURCING SERVICES LLC | 70677-1058 |
| Childrens Loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | Strategic Sourcing Services LLC | 62011-0305 |
| Childrens Loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2073 |
| childrens allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Publix Super Markets Inc | 56062-092 |
| Childrens Loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2085 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2131 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | H E B | 37808-131 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | American Sales Company | 41520-131 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8286 |