Over-the-counter drug · ANDA
Allergy Relief (Loratadine 10mg) NDC 53117-414
Loratadine 10 mg/1 · Tablet · Oral · First Aid Direct
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53117-414-85 | 53117041485 | 2 BLISTER PACK in 1 CARTON (53117-414-85) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 11, 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)
- Allergy Relief
- Generic name (nonproprietary)
- loratadine 10mg
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- First Aid DirectNDC labeler code 53117
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
- Marketing start
- Listing expires
- Identifiers
- Product ID 53117-414_2951457f-e466-43c5-a39e-274c36098613SPL ID 2951457f-e466-43c5-a39e-274c36098613SPL set ID 3a580dc7-ff09-462c-9b18-205105349035RxCUI 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
N453117041485followed by a unit qualifier and the quantityPackage 53117-0414-85. 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)
Use(s) 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 53117-414
- What is NDC 53117-414?
- 53117-414 is the product NDC for Allergy Relief (loratadine 10mg), Loratadine 10 mg/1 tablet, listed with the FDA by First Aid Direct. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allergy Relief (Loratadine 10mg).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- First Aid Direct, NDC labeler code 53117. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allergy Relief?
- 263 other product NDCs are listed under this name. See all 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 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) |
|---|---|---|---|---|---|
| Allergy Relieflevocetirizine dihydrochloride usp, 5 mg | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Topco Associates, LLC | 76162-915 | 76162-0915-3576162-0915-80 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-391 | 72288-0391-0172288-0391-78 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0771 | 70000-0771-0170000-0771-02 |
| Allergy Relieflevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-784 | 72288-0784-27 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Orally disintegratingOral | Meijer, Inc. | 79481-9723 | 79481-9723-01 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-434 | 75907-0434-0175907-0434-30 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | Kroger Company | 30142-856 | 30142-0856-62 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | NUVICARE LLC | 84324-040 | 84324-0040-01 |
| Allergy Reliefcetirizine tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | DISCOUNT DRUG MART, INC | 53943-130 | 53943-0130-1353943-0130-17 |
| Allergy Relieffluticasone propionate | Fluticasone propionate 50 ug/1 | Spray, MeteredNasal | P & L Development, LLC | 59726-203 | 59726-0203-3859726-0203-54 |
Other NDCs under ANDA 210722
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 |
|---|---|---|---|---|
| Loratadine | Loratadine 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-831 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Allegiant Health | 69168-414 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | AMZ789 LLC | 73629-003 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | FSA STORE INC. | 81522-393 |
| Green Guard 24 Hour Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Unifirst First Aid Corporation | 47682-117 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | HARRIS TEETER | 72036-193 |
| Curist Allergy Reliefloratadine 10 mg | Loratadine 10 mg/1 | TabletOral | Little Pharma, Inc. | 72559-033 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | GRANULES USA, INC. | 69848-019 |
| Loratadine 10mg | Loratadine 10 mg/1 | TabletOral | Meijer | 79481-7870 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bi-Mart | 37835-621 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8659 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | AMERIFOODS TRADING COMPANY | 61504-193 |
| CAREALL Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | New World Imports | 51824-103 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | DISCOUNT DRUG MART | 53943-193 |
| ALLERGY RELIEF 10 mgloratadine | Loratadine 10 mg/1 | TabletOral | TWIN MED LLC | 55681-303 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2529 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Safeway, Inc | 21130-780 |
| Medique Loradamedloratadine | Loratadine 10 mg/1 | TabletOral | Unifirst First Aid Corporation | 47682-403 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Marc Glassman, Inc. | 68998-414 |
| Dr Simi All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-201 |
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