Over-the-counter drug · ANDA
TopCare Allergy Relief 24 hour (Loratadine) NDC 36800-612
Loratadine 10 mg/1 · Tablet · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-612-03 | 3680006120336800061203 | 1 BOTTLE in 1 CARTON (36800-612-03) / 70 TABLET in 1 BOTTLEMarketed from Mar 5, 2014 | |
| 36800-612-46 | 3680006124636800061246 | 10 BLISTER PACK in 1 CARTON (36800-612-46) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 28, 2005 | |
| 36800-612-58 | 3680006125836800061258 | 1 BOTTLE in 1 CARTON (36800-612-58) / 40 TABLET in 1 BOTTLEMarketed from Feb 19, 2014 | |
| 36800-612-65 | 3680006126536800061265 | 1 BOTTLE in 1 CARTON (36800-612-65) / 30 TABLET in 1 BOTTLEMarketed from Jan 25, 2005 | |
| 36800-612-87 | 3680006128736800061287 | 1 BOTTLE in 1 CARTON (36800-612-87) / 300 TABLET in 1 BOTTLEMarketed from Dec 18, 2009 |
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)
- TopCare Allergy Relief 24 hourSuffix: 24 hour
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 36800
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-612_9fd9c4c8-9520-470a-9deb-e050233a6e92SPL ID 9fd9c4c8-9520-470a-9deb-e050233a6e92SPL set ID a500aebf-a020-4da9-afdb-a699077cb8e1RxCUI 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
N436800061203followed by a unit qualifier and the quantityPackage 36800-0612-03. 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 36800-612
- What is NDC 36800-612?
- 36800-612 is the product NDC for TopCare Allergy Relief 24 hour (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by Topco Associates LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TopCare Allergy Relief 24 hour (Loratadine).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TopCare Allergy Relief 24 hour?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 | Padagis Israel Pharmaceuticals Ltd | 45802-650 |
| 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 |
| 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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