Over-the-counter drug · ANDA
Loratadine NDC 69848-019
Loratadine 10 mg/1 · Tablet · Oral · GRANULES USA, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69848-019-10 | 69848001910 | 100 TABLET in 1 BOTTLE (69848-019-10)Marketed from Jul 26, 2021 |
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
- GRANULES USA, INC.NDC labeler code 69848
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
- Marketing start
- Listing expires
- Identifiers
- Product ID 69848-019_469099a1-3de4-d107-e063-6294a90adf16SPL ID 469099a1-3de4-d107-e063-6294a90adf16SPL set ID c3c9bc45-7ed5-abf4-e053-2995a90a40ffRxCUI 311372UNII 7AJO3BO7QNUPC 0813874020032
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
N469848001910followed by a unit qualifier and the quantityPackage 69848-0019-10. 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.
About NDC 69848-019
- What is NDC 69848-019?
- 69848-019 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by GRANULES USA, INC.. It has 1 package NDC, 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?
- GRANULES USA, INC., NDC labeler code 69848. 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?
- 108 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 210722
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 |
|---|---|---|---|---|
| 24 / 7 Life Non-Drowsy Allergy Reliefloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 29485-8156 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Spirit Pharmaceuticals LLC | 68210-4110 |
| ValuMeds Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1042 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Grocery Outlet, Inc | 85828-193 |
| 24 / 7 Life Non-Drowsy Allergy Reliefloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 29485-5515 |
| McKesson Loradatineloratainde | Loratadine 10 mg/1 | TabletOral | McKesson Medical Surgical | 68599-4785 |
| Medi-First Plus Allery Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Unifirst First Aid Corporation | 47682-912 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3596 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Advanced Rx LLC | 80513-711 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | AAA PHARMACEUTICAL, INC. | 57344-193 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-162 |
| XL - 3 Allergy | Loratadine 10 mg/1 | TabletOral | Selder, S.A. de C.V. | 63654-415 |
| First Aid Direct Allergy Reliefloratadine tablets | Loratadine 10 mg/1 | TabletOral | Cintas Corporation | 42961-120 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Granules India Limited | 62207-787 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2431 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Allegiant Health | 69168-414 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | AMZ789 LLC | 73629-003 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | FSA STORE INC. | 81522-393 |
| Green Guard 24 Hour Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Unifirst First Aid Corporation | 47682-117 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HARRIS TEETER | 72036-193 |
Showing 20 of 39.