Over-the-counter drug · ANDA
Childrens Loratadine Sugar Free (Loratadine) NDC 37808-131
Loratadine 5 mg/5mL · Solution · Oral · H E B
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-131-08 | 3780801310837808013108 | 1 BOTTLE in 1 CARTON (37808-131-08) / 120 mL in 1 BOTTLEMarketed from Apr 16, 2018 |
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 Loratadine Sugar FreeSuffix: Sugar Free
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- H E BNDC labeler code 37808
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076805
- Marketing start
- Listing expires
- Identifiers
- Product ID 37808-131_3c5477aa-2b46-b58a-e063-6294a90aeaf5SPL ID 3c5477aa-2b46-b58a-e063-6294a90aeaf5SPL set ID d710b760-794e-490b-a413-c7b2ee5149b9RxCUI 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
N437808013108followed by a unit qualifier and the quantityPackage 37808-0131-08. 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 itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 37808-131
- What is NDC 37808-131?
- 37808-131 is the product NDC for Childrens Loratadine Sugar Free (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by H E B. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Loratadine Sugar Free (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- H E B, NDC labeler code 37808. 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 Sugar Free?
- 6 other product NDCs are listed under this name. See all Childrens Loratadine Sugar Free 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 Sugar Free 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 Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | STRATEGIC SOURCING SERVICES LLC | 70677-1058 | 70677-1058-01 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8286 | 68788-8286-01 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Walgreen Company | 0363-2131 | 00363-2131-08 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | American Sales Company | 41520-131 | 41520-0131-08 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2131 | 51672-2131-0151672-2131-0451672-2131-08 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2108 | 51672-2108-0151672-2108-08 |
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 |
| Loratadine | Loratadine 5 mg/5mL | SolutionOral | Cardinal Health, 110 dba LEADER | 70000-0125 |
| Childrens Loratadine Sugar Freeloratadine | Loratadine 5 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2131 |
| 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 |