Over-the-counter drug · ANDA
First Aid Direct Allergy Relief (Loratadine tablets) NDC 42961-120
Loratadine 10 mg/1 · Tablet · Oral · Cintas Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42961-120-02 | 4296101200242961012002 | 2 BLISTER PACK in 1 BOX (42961-120-02) / 10 TABLET in 1 BLISTER PACKMarketed from Oct 20, 2021 |
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)
- First Aid Direct Allergy Relief
- Generic name (nonproprietary)
- loratadine tablets
- Active ingredients
- Loratadine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cintas CorporationNDC labeler code 42961
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
- Marketing start
- Listing expires
- Identifiers
- Product ID 42961-120_698cf169-c537-491e-9e70-b920b627761eSPL ID 698cf169-c537-491e-9e70-b920b627761eSPL set ID 6b43e5a5-30a8-46ca-a44d-1e1abf567b51RxCUI 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
N442961012002followed by a unit qualifier and the quantityPackage 42961-0120-02. 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 temporatily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing iching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 42961-120
- What is NDC 42961-120?
- 42961-120 is the product NDC for First Aid Direct Allergy Relief (loratadine tablets), Loratadine 10 mg/1 tablet, listed with the FDA by Cintas Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- First Aid Direct Allergy Relief (Loratadine Tablets).
- What is the active ingredient?
- Loratadine.
- Who is the labeler?
- Cintas Corporation, NDC labeler code 42961. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for First Aid Direct Allergy Relief?
- 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 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 |
|---|---|---|---|---|
| Medi-First Plus Allery Reliefloratadine | Loratadine 10 mg/1 | TabletOral | Unifirst First Aid Corporation | 47682-912 |
| 24 / 7 Life Non-Drowsy Allergy Reliefloratadine tablet | Loratadine 10 mg/1 | TabletOral | Lil' Drug Store Products, Inc. | 29485-8156 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2431 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8659 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | GRANULES USA, INC. | 69848-019 |
| Allergy Reliefloratadine 10mg | Loratadine 10 mg/1 | TabletOral | First Aid Direct | 53117-414 |
| 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 | HARRIS TEETER | 72036-193 |
| ALLERGY RELIEF 10 mgloratadine | Loratadine 10 mg/1 | TabletOral | TWIN MED LLC | 55681-303 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | FSA STORE INC. | 81522-393 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Camber Consumer Care Inc | 69230-328 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | WinCo Foods, LLC | 67091-493 |
| Curist Allergy Reliefloratadine 10 mg | Loratadine 10 mg/1 | TabletOral | Little Pharma, Inc. | 72559-033 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | AMZ789 LLC | 73629-003 |
| Loratadine 10mg | Loratadine 10 mg/1 | TabletOral | Meijer | 79481-7870 |
| Dr Simi All Day Allergy Reliefloratadine | Loratadine 10 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-201 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Walgreens | 0363-9787 |
| Loratadine | Loratadine 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2529 |
| Allergy Reliefloratadine | Loratadine 10 mg/1 | TabletOral | AAA PHARMACEUTICAL, INC. | 57344-193 |
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