NDC codes

FDA NDC Directory
Product NDC (as listed)63981-612Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63981-0612Add 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
63981-612-88639810612881 BOTTLE in 1 PACKAGE (63981-612-88) / 365 TABLET in 1 BOTTLEMarketed from Oct 15, 2010

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)
kirkland signature allerclear
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
Marketing start
Listing expires
Identifiers
Product ID 63981-612_39dbaef4-0637-4ba0-9af1-ccb87eb17dafSPL ID 39dbaef4-0637-4ba0-9af1-ccb87eb17dafSPL set ID 2074d52e-8c0a-4e69-bfb1-864ffc07e25fRxCUI 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

N463981061288 followed by a unit qualifier and the quantity

Package 63981-0612-88. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 076301

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

FDA NDC Directory listings under ANDA 076301
ProductStrengthForm · routeLabelerProduct NDC
LoratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7066
good sense allergy reliefloratadineLoratadine 10 mg/1TabletOralL. Perrigo Company0113-1612
basic care allergy reliefloratadineLoratadine 10 mg/1TabletOralAmazon.com Services LLC72288-612
foster and thrive allergy reliefloratadineLoratadine 10 mg/1TabletOralStrategic Sourcing Services LLC70677-1022
good sense allergy reliefloratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7049
good sense allergy reliefloratadineLoratadine 10 mg/1TabletOralL. Perrigo Company0113-0612
good sense allergy reliefloratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7048
good sense allergy reliefloratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7051
CareOne Allergy Relief 24 HourloratadineLoratadine 10 mg/1TabletOralAmerican Sales Company41520-612
equate allergy reliefloratadineLoratadine 10 mg/1TabletOralWal-Mart Stores Inc49035-612
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralHyVee Inc42507-612
LoratadineLoratadine 10 mg/1TabletOralMajor Pharmaceuticals0904-6852
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-347
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-0836
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC43353-259
TopCare Allergy Relief 24 hourloratadineLoratadine 10 mg/1TabletOralTopco Associates LLC36800-612
goodnow allergy reliefloratadineLoratadine 10 mg/1TabletOralGobrands, Inc82501-0612
LoratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-5532
LoratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7158
LoratadineLoratadine 10 mg/1TabletOralCardinal Health 107, LLC55154-0188

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