Over-the-counter drug · ANDA
Loratadine NDC 68016-094
Loratadine 10 mg/1 · Tablet · Oral · Chain Drug Consortium, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-094-10 | 68016009410 | 1 BLISTER PACK in 1 CARTON (68016-094-10) / 10 TABLET in 1 BLISTER PACKMarketed from Apr 16, 2018 | |
| 68016-094-30 | 68016009430 | 3 BLISTER PACK in 1 CARTON (68016-094-30) / 10 TABLET in 1 BLISTER PACKMarketed from Apr 16, 2018 | |
| 68016-094-60 | 68016009460 | 1 BOTTLE in 1 CARTON (68016-094-60) / 60 TABLET in 1 BOTTLEMarketed from Apr 16, 2018 | |
| 68016-094-90 | 68016009490 | 1 BOTTLE in 1 CARTON (68016-094-90) / 90 TABLET 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)
- Loratadine
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chain Drug Consortium, LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208314
- Marketing start
- Listing expires
- Identifiers
- Product ID 68016-094_29355692-7b20-4b38-8611-8a8f86e636a7SPL ID 29355692-7b20-4b38-8611-8a8f86e636a7SPL set ID 21199958-ac67-4f72-8a8c-4d7d31fa9da4RxCUI 311372UNII 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
N468016009410followed by a unit qualifier and the quantityPackage 68016-0094-10. 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 itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208314
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 |
|---|---|---|---|---|
| Loratadine | Loratadine 10 mg/1 | TabletOral | WALGREEN CO. | 0363-9603 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | McLane Company, Inc. | 57243-200 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | KROGER COMPANY | 30142-066 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cardinal Health | 70000-0583 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-119 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7426 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Aurohealth LLC | 58602-702 |
| 365 Whole Foods Market Loratadineloratadine | Loratadine 10 mg/1 | TabletOral | Whole Foods Market, Inc. | 42681-0053 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7752 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7753 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Winco Foods, LLC. | 67091-408 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4103 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Aurohealth LLC | 58602-831 |
| ALLERGY RELIEF 10mgloratadine | Loratadine 10 mg/1 | TabletOral | YYBA CORP | 73581-203 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Aurohealth LLC | 58602-847 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | YYBA CORP | 73581-229 |
| Amazon Basic Care Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Amazon.com Services LLC | 72288-452 |
| CONTAC Allergyloratadine | Loratadine 10 mg/1 | TabletOral | Vespyr Brands LLC | 71179-010 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | BluePoint Laboratories | 68001-438 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | CVS Pharmacy, Inc. | 69842-242 |