NDC codes

FDA NDC Directory
Product NDC (as listed)53943-193Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0193Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
53943-193-18539430193182 BOTTLE, PLASTIC in 1 CARTON (53943-193-18) / 90 TABLET in 1 BOTTLE, PLASTICMarketed from Jul 6, 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)
Allergy Relief
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
Marketing start
Listing expires
Identifiers
Product ID 53943-193_c6f315a9-9341-db6c-e053-2a95a90a1b2fSPL ID c6f315a9-9341-db6c-e053-2a95a90a1b2fSPL set ID c29bf35f-1f19-c3c9-e053-2995a90ac1b6RxCUI 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

N453943019318 followed by a unit qualifier and the quantity

Package 53943-0193-18. 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 sneezing itchy, watery eyes itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210722

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210722
ProductStrengthForm · routeLabelerProduct NDC
McKesson LoradatinelorataindeLoratadine 10 mg/1TabletOralMcKesson Medical Surgical68599-4785
ValuMeds Allergy ReliefloratadineLoratadine 10 mg/1TabletOralCabinet Health P.B.C.82725-1042
LoratadineLoratadine 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3596
XL - 3 AllergyLoratadine 10 mg/1TabletOralSelder, S.A. de C.V.63654-415
LoratadineLoratadine 10 mg/1TabletOralSpirit Pharmaceuticals LLC68210-4110
First Aid Direct Allergy Reliefloratadine tabletsLoratadine 10 mg/1TabletOralCintas Corporation42961-120
LoratadineLoratadine 10 mg/1TabletOralAdvanced Rx LLC80513-711
LoratadineLoratadine 10 mg/1TabletOralGranules Pharmaceuticals Inc.70010-162
LoratadineLoratadine 10 mg/1TabletOralGranules India Limited62207-787
Green Guard 24 Hour Allergy ReliefloratadineLoratadine 10 mg/1TabletOralUnifirst First Aid Corporation47682-117
LoratadineLoratadine 10 mg/1TabletOralBryant Ranch Prepack71335-2431
LoratadineLoratadine 10 mg/1TabletOralWalgreens0363-9787
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralAllegiant Health69168-414
LoratadineLoratadine 10 mg/1TabletOralAMZ789 LLC73629-003
LoratadineLoratadine 10 mg/1TabletOralBi-Mart37835-621
Curist Allergy Reliefloratadine 10 mgLoratadine 10 mg/1TabletOralLittle Pharma, Inc.72559-033
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralHARRIS TEETER72036-193
LoratadineLoratadine 10 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-831
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralValu Merchandisers Company63941-193
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralFSA STORE INC.81522-393

Showing 20 of 39.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in