Over-the-counter drug · ANDA
Loratadine NDC 59556-301
Loratadine 5 mg/1 · Tablet · Oral · Strides Pharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59556-301-01 | 5955603010159556030101 | 1 BLISTER PACK in 1 CARTON (59556-301-01) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 10, 2021 | |
| 59556-301-02 | 5955603010259556030102 | 2 BLISTER PACK in 1 CARTON (59556-301-02) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 10, 2021 | |
| 59556-301-03 | 5955603010359556030103 | 3 BLISTER PACK in 1 CARTON (59556-301-03) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 10, 2021 | |
| 59556-301-04 | 5955603010459556030104 | 4 BLISTER PACK in 1 CARTON (59556-301-04) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 10, 2021 | |
| 59556-301-05 | 5955603010559556030105 | 5 BLISTER PACK in 1 CARTON (59556-301-05) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 10, 2021 | |
| 59556-301-06 | 5955603010659556030106 | 6 BLISTER PACK in 1 CARTON (59556-301-06) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 10, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Strides Pharma IncNDC labeler code 59556
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212795
- Marketing start
- Listing expires
- Identifiers
- Product ID 59556-301_0df121d3-d783-620c-e063-6294a90acdabSPL ID 0df121d3-d783-620c-e063-6294a90acdabSPL set ID a54cdbe9-32ec-45ca-948f-9cefbb8e3cbfRxCUI 672558UNII 7AJO3BO7QNUPC 0359556301018
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
N459556030101followed by a unit qualifier and the quantityPackage 59556-0301-01. 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 59556-301
- What is NDC 59556-301?
- 59556-301 is the product NDC for Loratadine, Loratadine 5 mg/1 tablet, listed with the FDA by Strides Pharma 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?
- Strides Pharma Inc, NDC labeler code 59556. 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 212795
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 |
|---|---|---|---|---|
| Allervarxloratadine | Loratadine 5 mg/1 | Tablet, Orally disintegratingOral | Innovus Pharmaceuticals, Inc. | 57483-955 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Walgreens Company | 0363-9955 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 43598-756 |
| Loratadine | Loratadine 5 mg/1 | Tablet, Orally disintegratingOral | CVS PHARMACY, INC | 51316-502 |
| Loratadine | Loratadine 5 mg/1 | TabletOral | Tenshi Kaizen Pvt Ltd | 72983-500 |