NDC codes

FDA NDC Directory
Product NDC (as listed)69452-211Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69452-0211Add 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
69452-211-0369452021103694520211031 BOTTLE in 1 CARTON (69452-211-03) / 5 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Mar 1, 2019
69452-211-0769452021107694520211071 BLISTER PACK in 1 CARTON (69452-211-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Mar 1, 2019
69452-211-1669452021116694520211161 BOTTLE in 1 CARTON (69452-211-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Mar 1, 2019
69452-211-2669452021126694520211261 BOTTLE in 1 CARTON (69452-211-26) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Mar 1, 2019

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)
Loratadine
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Labeler
Bionpharma Inc.NDC labeler code 69452
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202538
Marketing start
Listing expires
Identifiers
Product ID 69452-211_932678d1-e6bf-4154-ac00-b6b9c9fbd16eSPL ID 932678d1-e6bf-4154-ac00-b6b9c9fbd16eSPL set ID 59bebce3-2b82-4521-a796-2d4c83bcf669RxCUI 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

N469452021103 followed by a unit qualifier and the quantity

Package 69452-0211-03. 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)

About NDC 69452-211

What is NDC 69452-211?
69452-211 is the product NDC for Loratadine, Loratadine 10 mg/1 capsule, liquid filled, listed with the FDA by Bionpharma Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Loratadine.
What is the active ingredient?
Loratadine.
Who is the labeler?
Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Loratadine?
109 other product NDCs are listed under this name. See all Loratadine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Loratadine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LoratadineLoratadine 10 mg/1TabletOralYYBA CORP73581-22973581-0229-0173581-0229-03
LoratadineLoratadine 10 mg/1TabletOralAvPAK50268-77750268-0777-01
LoratadineLoratadine 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-410368788-4103-0068788-4103-0168788-4103-03+2 more
LoratadineLoratadine 10 mg/1TabletOralSafecor Health, LLC48433-06448433-0064-20
LoratadineLoratadine 10 mg/1TabletOralAurobindo Pharma Limited84386-11984386-0119-78
LoratadineLoratadine 10 mg/1TabletOralCabinet Health P.B.C.82725-014282725-0142-0182725-0142-0282725-0142-03+1 more
LoratadineLoratadine 10 mg/1TabletOralCardinal Health 107, LLC55154-018855154-0188-00
LoratadineLoratadine 10 mg/1TabletOralMajor Pharmaceuticals0904-751100904-7511-61
LoratadineLoratadine 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-865968788-8659-0068788-8659-0168788-8659-03+2 more
LoratadineLoratadine 10 mg/1Tablet, Orally disintegratingOralTenshi Kaizen Pvt Ltd72983-50372983-0503-06

All 110 Loratadine NDCs

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
allergy reliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralMeijer, Inc.79481-0446
Basic Care Allergy ReliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralAmazon.com Services LLC72288-446
dg health allergy reliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralDolgencorp Inc55910-629
LoratadineLoratadine 10 mg/1Capsule, Liquid filledOralBionpharma Inc.69452-283
topcare allergy reliefloratadineLoratadine 10 mg/1Capsule, Liquid filledOralTopco Associates LLC36800-755

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