Over-the-counter drug · ANDA
Loratadine ODT (Loratadine) NDC 46122-539
Loratadine 10 mg/1 · Tablet, Orally disintegrating · Oral · Amerisource Bergen
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46122-539-52 | 4612205395246122053952 | 1 BLISTER PACK in 1 CARTON (46122-539-52) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jul 9, 2018 | |
| 46122-539-65 | 4612205396546122053965 | 3 BLISTER PACK in 1 CARTON (46122-539-65) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 10, 2022 |
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 ODT
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Amerisource BergenNDC labeler code 46122
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208477
- Marketing start
- Listing expires
- Identifiers
- Product ID 46122-539_64ce24cf-4a83-4d87-a5c8-0e9a7589fb13SPL ID 64ce24cf-4a83-4d87-a5c8-0e9a7589fb13SPL set ID d2524455-b6c4-442b-b139-666a555c5298RxCUI 311373UNII 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
N446122053952followed by a unit qualifier and the quantityPackage 46122-0539-52. 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 46122-539
- What is NDC 46122-539?
- 46122-539 is the product NDC for Loratadine ODT (loratadine), Loratadine 10 mg/1 tablet, orally disintegrating, listed with the FDA by Amerisource Bergen. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine ODT (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Amerisource Bergen, NDC labeler code 46122. 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 ODT?
- 12 other product NDCs are listed under this name. See all Loratadine ODT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loratadine ODT 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 ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Better Living Brands, LLC | 21130-221 | 21130-0221-84 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Rugby Laboratories | 0536-1367 | 00536-1367-07 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-881 | 58602-0881-15 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | WALGREEN CO. | 0363-9937 | 00363-9937-84 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Wal-Mart Stores, Inc. | 49035-806 | 49035-0806-09 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | DISCOUNT DRUG MART | 53943-035 | 53943-0035-03 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-744 | 58602-0744-8358602-0744-84 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-821 | 58602-0821-8358602-0821-84 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-830 | 58602-0830-83 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Ahold U.S.A., Inc, | 60000-950 | 60000-0950-83 |
Other NDCs under ANDA 208477
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 |
|---|---|---|---|---|
| Childrens Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | WALGREEN CO. | 0363-4020 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | WALGREEN CO. | 0363-9937 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Rugby Laboratories | 0536-1367 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Better Living Brands, LLC | 21130-221 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Wal-Mart Stores, Inc. | 49035-806 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | DISCOUNT DRUG MART | 53943-035 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-744 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-821 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-830 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-881 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Ahold U.S.A., Inc, | 60000-950 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Chain Drug Consortium, LLC | 68016-088 |
| Loratadine ODTloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | CVS Pharmacy, Inc. | 69842-085 |