NDC codes

FDA NDC Directory
Product NDC (as listed)79481-0446Labeler and product segments. Claims need a package NDC.
Product NDC at billing width79481-0446Add 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
79481-0446-07948104460030 BLISTER PACK in 1 CARTON (79481-0446-0) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Jul 14, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Capsule, Liquid filled
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202538
Marketing start
Listing expires
Identifiers
Product ID 79481-0446_73b95703-51ba-4e0e-a343-00e24ef815c3SPL ID 73b95703-51ba-4e0e-a343-00e24ef815c3SPL set ID 14f3d1a2-eda7-432a-8fe0-5437b95bdde6RxCUI 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

N479481044600 followed by a unit qualifier and the quantity

Package 79481-0446-00. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202538

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

FDA NDC Directory listings under ANDA 202538
ProductStrengthForm · routeLabelerProduct NDC
dg health allergy reliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralDolgencorp Inc55910-629
topcare allergy reliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralTopco Associates LLC36800-755
LoratadineLoratadine 10 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-211
Basic Care Allergy ReliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralAmazon.com Services LLC72288-446
LoratadineLoratadine 10 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-283

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