Over-the-counter drug · ANDA
Childrens Loratadine Sugar Free (loratadine) NDC 51672-2131
Loratadine 5 mg/5mL · Solution · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-2131-1 | 51672213101 | 1 BOTTLE in 1 CARTON (51672-2131-1) / 240 mL in 1 BOTTLEMarketed from Mar 17, 2017 | |
| 51672-2131-4 | 51672213104 | 1 BOTTLE in 1 CARTON (51672-2131-4) / 60 mL in 1 BOTTLEMarketed from Mar 17, 2017 | |
| 51672-2131-8 | 51672213108 | 1 BOTTLE in 1 CARTON (51672-2131-8) / 120 mL in 1 BOTTLEMarketed from Mar 17, 2017 |
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)
- Childrens Loratadine Sugar FreeSuffix: Sugar Free
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076805
- Marketing start
- Listing expires
- Identifiers
- Product ID 51672-2131_5a4df9e7-54bd-7382-e063-6394a90aa38dSPL ID 5a4df9e7-54bd-7382-e063-6394a90aa38dSPL set ID 58eaab62-ac36-4080-8ded-9b472dddc617RxCUI 692783UNII 7AJO3BO7QNUPC 0351672213183
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
N451672213101followed by a unit qualifier and the quantityPackage 51672-2131-01. 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.
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 |
|---|---|---|---|---|
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | STRATEGIC SOURCING SERVICES LLC | 70677-1058 |
| Good Neighbor Pharmacy Childrens Loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | AmerisourceBergen | 24385-531 |
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | STRATEGIC SOURCING SERVICES LLC | 70677-1057 |
| 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 Loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2085 |
| childrens allergyloratadine | Loratadine 5 mg/5mL | SolutionOral | Publix Super Markets Inc | 56062-092 |
| Sunmark childrens loratadineloratadine | Loratadine 5 mg/5mL | SolutionOral | Strategic Sourcing Services LLC | 49348-636 |
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | Cardinal Health, 110 dba LEADER | 70000-0125 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8286 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Walgreen Company | 0363-2131 |
| 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 |