Over-the-counter drug · ANDA
Loratadine NDC 68788-8616
Loratadine 10 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8616-0 | 6878886160068788861600 | 100 TABLET in 1 BOTTLE (68788-8616-0)Marketed from Mar 26, 2024 | |
| 68788-8616-1 | 6878886160168788861601 | 14 TABLET in 1 BOTTLE (68788-8616-1)Marketed from Mar 26, 2024 | |
| 68788-8616-3 | 6878886160368788861603 | 30 TABLET in 1 BOTTLE (68788-8616-3)Marketed from Mar 26, 2024 | |
| 68788-8616-5 | 6878886160568788861605 | 15 TABLET in 1 BOTTLE (68788-8616-5)Marketed from Mar 26, 2024 | |
| 68788-8616-8 | 6878886160868788861608 | 10 TABLET in 1 BOTTLE (68788-8616-8)Marketed from May 21, 2024 | |
| 68788-8616-9 | 6878886160968788861609 | 90 TABLET in 1 BOTTLE (68788-8616-9)Marketed from Mar 26, 2024 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals IncNDC labeler code 68788
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214684
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-8616_8d420971-3031-42af-9fbb-22a99001f291SPL ID 8d420971-3031-42af-9fbb-22a99001f291SPL set ID 0a0d700d-bdba-4c90-a947-5d61d40ce4dfRxCUI 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
N468788861600followed by a unit qualifier and the quantityPackage 68788-8616-00. 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 respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 68788-8616
- What is NDC 68788-8616?
- 68788-8616 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc. It has 6 package NDCs, 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?
- Preferred Pharmaceuticals Inc, NDC labeler code 68788. 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 214684
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 |
|---|---|---|---|---|
| CVS Loratadineloratadine | Loratadine 10 mg/1 | TabletOral | CVS Pharmacy | 51316-184 |
| Gencare-Allergy Relief Loratadine Tablets, 10 mgloratadine | Loratadine 10 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-051 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Rising Pharmaceuticals, Inc | 16571-822 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-8075 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-5308 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Strategic Sourcing Services, LLC | 70677-1240 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0352 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Gobrands, Inc | 82501-1580 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-0142 |
| Nuvicare-Allergy Relief Loratadine Tablets, 10 mgloratadine | Loratadine 10 mg/1 | TabletOral | NUVICARE LLC | 84324-027 |
| ValuMeds Allergy Relief Loratadineloratadine | Loratadine 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1142 |