Over-the-counter drug · ANDA
Topcare Allergy Relief (Loratadine) NDC 36800-853
Loratadine 10 mg/1 · Tablet, Orally disintegrating · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-853-65 | 36800085365 | 30 BLISTER PACK in 1 CARTON (36800-853-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jun 25, 2020 |
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
- Generic name (nonproprietary)
- loratadine
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- 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 076011
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-853_4bd57bff-c68b-497f-801d-e60d9c7b8390SPL ID 4bd57bff-c68b-497f-801d-e60d9c7b8390SPL set ID 32f4e1d1-c830-4752-8251-bcc233bf03f6RxCUI 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
N436800085365followed by a unit qualifier and the quantityPackage 36800-0853-65. 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 36800-853
- What is NDC 36800-853?
- 36800-853 is the product NDC for Topcare Allergy Relief (loratadine), Loratadine 10 mg/1 tablet, orally disintegrating, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topcare Allergy Relief (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?
- 3 other product NDCs are listed under this name. See all Topcare Allergy Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Topcare Allergy Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| topcare allergy relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-691 | 36800-0691-3936800-0691-4936800-0691-75 |
| TopCare Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TOPCO ASSOCIATES LLC | 36800-367 | 36800-0367-24 |
| topcare allergy reliefloratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 36800-755 | 36800-0755-3936800-0755-52 |
Other NDCs under ANDA 076011
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 |
|---|---|---|---|---|
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | L. Perrigo Company | 0113-1191 |
| Basic Care Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Amazon.com Services LLC | 72288-451 |
| signature care allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Safeway | 21130-452 |
| careone allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | American Sales Company | 41520-510 |
| dg health allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Dolgencorp, LLC | 55910-970 |
| equate loratadineloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | WALMART INC. | 79903-381 |
| dg health allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Dolgencorp, LLC | 55910-594 |
| non drowsy allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer Distribution Inc | 41250-890 |
| loratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Rite Aid Corporation | 11822-0558 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-931 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer, Inc. | 79481-9723 |
| Basic Care Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Amazon.com Services LLC | 72288-200 |
| good sense allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | L. Perrigo Company | 0113-9755 |
| allergy reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Kroger Company | 30142-446 |