Over-the-counter drug · ANDA
Loratadine ODT (loratadine) NDC 68016-088
Loratadine 10 mg/1 · Tablet, Orally disintegrating · Oral · Chain Drug Consortium, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-088-10 | 68016008810 | 1 BLISTER PACK in 1 CARTON (68016-088-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Apr 11, 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)
- Loratadine ODT
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Chain Drug Consortium, LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208477
- Marketing start
- Listing expires
- Identifiers
- Product ID 68016-088_38d1e80f-4bba-4acb-bc49-89bd3653c2cdSPL ID 38d1e80f-4bba-4acb-bc49-89bd3653c2cdSPL set ID 7674009d-492d-4005-a652-f12b91428c0dRxCUI 311373UNII 7AJO3BO7QNUPC 0358602744830
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
N468016008810followed by a unit qualifier and the quantityPackage 68016-0088-10. 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 sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208477
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 ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | WALGREEN CO. | 0363-4020 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Ahold U.S.A., Inc, | 60000-950 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | WALGREEN CO. | 0363-9937 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | DISCOUNT DRUG MART | 53943-035 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Wal-Mart Stores, Inc. | 49035-806 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Wal-Mart Stores, Inc. | 49035-806 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-744 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Rugby Laboratories | 0536-1367 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Amerisource Bergen | 46122-539 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-821 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-830 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | CVS Pharmacy, Inc. | 69842-085 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Better Living Brands, LLC | 21130-221 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-881 |