Over-the-counter drug · ANDA
Loratadine (Loratadine oral) NDC 21130-042
Loratadine 5 mg/5mL · Solution · Oral · Better Living Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-042-24 | 2113000422421130004224 | 1 BOTTLE in 1 CARTON (21130-042-24) / 120 mL in 1 BOTTLEMarketed from Sep 25, 2023 |
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 oral
- Active ingredients
- Loratadine — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Better Living Brands LLCNDC labeler code 21130
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208931
- Marketing start
- Listing expires
- Identifiers
- Product ID 21130-042_b0412b0b-32e8-49a6-b62a-717290693d7eSPL ID b0412b0b-32e8-49a6-b62a-717290693d7eSPL set ID f7dc7a3d-6709-d7e7-e053-6394a90acde8RxCUI 692783UNII 7AJO3BO7QNUPC 0321130787297
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
N421130004224followed by a unit qualifier and the quantityPackage 21130-0042-24. 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.
About NDC 21130-042
- What is NDC 21130-042?
- 21130-042 is the product NDC for Loratadine (loratadine oral), Loratadine 5 mg/5mL solution, listed with the FDA by Better Living Brands LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine (Loratadine Oral).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Better Living Brands LLC, NDC labeler code 21130. 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?
- 107 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 208931
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 |
|---|---|---|---|---|
| Loratadineloratadine oral | Loratadine 5 mg/5mL | SolutionOral | KROGER COMPANY | 30142-062 |
| Loratadineloratadine oral | Loratadine 5 mg/5mL | SolutionOral | Aurohealth LLC | 58602-423 |
| Loratadineloratadine oral | Loratadine 5 mg/5mL | SolutionOral | BluePoint Laboratories | 68001-449 |