Over-the-counter drug · ANDA
Loratadine antihistamine (Loratadine) NDC 45802-650
Loratadine 10 mg/1 · Tablet · Oral · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC DirectoryProduct NDC (as listed)45802-650Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45802-0650Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-650-65 | 4580206506545802065065 | 1 BOTTLE in 1 CARTON (45802-650-65) / 30 TABLET in 1 BOTTLEMarketed from Oct 15, 2008 | |
| 45802-650-75 | 4580206507545802065075 | 1 BOTTLE in 1 CARTON (45802-650-75) / 90 TABLET in 1 BOTTLEMarketed from Sep 15, 2023 | |
| 45802-650-78 | 4580206507845802065078 | 1 BOTTLE in 1 CARTON (45802-650-78) / 100 TABLET in 1 BOTTLEMarketed from Oct 7, 2009 | |
| 45802-650-87 | 4580206508745802065087 | 1 BOTTLE in 1 CARTON (45802-650-87) / 300 TABLET in 1 BOTTLEMarketed from Oct 28, 2008 |
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 antihistamineSuffix: antihistamine
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
- Marketing start
- Listing expires
- Identifiers
- Product ID 45802-650_497be46d-b620-41ae-bac0-95ef0bd94fe4SPL ID 497be46d-b620-41ae-bac0-95ef0bd94fe4SPL set ID c72d8a30-520e-4d25-8f02-0c891e070a1aRxCUI 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
N445802065065followed by a unit qualifier and the quantityPackage 45802-0650-65. 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 45802-650
- What is NDC 45802-650?
- 45802-650 is the product NDC for Loratadine antihistamine (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loratadine antihistamine (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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 antihistamine?
- 8 other product NDCs are listed under this name. See all Loratadine antihistamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loratadine antihistamine 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 antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8217 | 00615-8217-3000615-8217-39 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-259 | 43353-0259-0943353-0259-1843353-0259-60 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-0836 | 50090-0836-0050090-0836-0450090-0836-05 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Proficient Rx LP | 63187-601 | 63187-0601-1063187-0601-1463187-0601-30+2 more |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-653 | 66267-0653-0766267-0653-1066267-0653-14+4 more |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3414 | 68071-3414-03 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-347 | 72789-0347-1472789-0347-2072789-0347-30+2 more |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-380 | 72789-0380-15 |
Other NDCs under ANDA 076301
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 |
|---|---|---|---|---|
| goodnow allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Gobrands, Inc | 82501-0612 |
| CareOne Allergy Relief 24 Hourloratadine | Loratadine 10 mg/1 | TabletOral | American Sales Company | 41520-612 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Kroger Company | 30142-612 |
| Leader Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Cardinal Health 110, LLC. dba Leader | 70000-0213 |
| good neighbor pharmacy loratadineloratadine | Loratadine 10 mg/1 | TabletOral | Amerisource Bergen | 24385-471 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6852 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-347 |
| up and up allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Target Corporation | 11673-612 |
| dg health allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dolgencorp Inc | 55910-806 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-380 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7048 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7049 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7051 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Proficient Rx LP | 63187-601 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-259 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8217 |
| equate allergy reliefloratadine | Loratadine 10 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-612 |
| TopCare Allergy Relief 24 hourloratadine | Loratadine 10 mg/1 | TabletOral | Topco Associates LLC | 36800-612 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7066 |
| Loratadine antihistamineloratadine | Loratadine 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-653 |
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