Over-the-counter drug · ANDA
topcare allergy relief (Loratadine) NDC 36800-755
Loratadine 10 mg/1 · Capsule, Liquid filled · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36800-755-39 | 3680007553936800075539 | 30 BLISTER PACK in 1 CARTON (36800-755-39) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 2, 2020 | |
| 36800-755-52 | 3680007555236800075552 | 10 BLISTER PACK in 1 CARTON (36800-755-52) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Aug 2, 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
- Capsule, Liquid filled
- 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 202538
- Marketing start
- Listing expires
- Identifiers
- Product ID 36800-755_b03bf6f6-62bb-458f-ad7d-046defb8bf9bSPL ID b03bf6f6-62bb-458f-ad7d-046defb8bf9bSPL set ID 5cc2e469-9080-4beb-804d-187fc335ccdcRxCUI 828269UNII 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
N436800075539followed by a unit qualifier and the quantityPackage 36800-0755-39. 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 36800-755
- What is NDC 36800-755?
- 36800-755 is the product NDC for topcare allergy relief (loratadine), Loratadine 10 mg/1 capsule, liquid filled, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, 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 | Tablet, Orally disintegratingOral | Topco Associates LLC | 36800-853 | 36800-0853-65 |
Other NDCs under ANDA 202538
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 |
|---|---|---|---|---|
| allergy reliefloratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | Meijer, Inc. | 79481-0446 |
| Basic Care Allergy Reliefloratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | Amazon.com Services LLC | 72288-446 |
| dg health allergy reliefloratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | Dolgencorp Inc | 55910-629 |
| Loratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-211 |
| Loratadine | Loratadine 10 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-283 |