Over-the-counter drug · ANDA

Loratadine antihistamine (Loratadine) NDC 0615-8217

Loratadine 10 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8217Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8217Add 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
0615-8217-30006158217306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8217-30) / 5 TABLET in 1 BLISTER PACKMarketed from Dec 19, 2025
0615-8217-390061582173930 TABLET in 1 BLISTER PACK (0615-8217-39)Marketed from Nov 20, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 antihistamineSuffix: antihistamine
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076301
Marketing start
Listing expires
Identifiers
Product ID 0615-8217_795e1026-4893-4066-891a-3dec5223db50SPL ID 795e1026-4893-4066-891a-3dec5223db50SPL set ID f3d05276-21bd-419d-8dba-07ce278d3375RxCUI 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

N400615821730 followed by a unit qualifier and the quantity

Package 00615-8217-30. 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 0615-8217

What is NDC 0615-8217?
0615-8217 is the product NDC for Loratadine antihistamine (loratadine), Loratadine 10 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Loratadine antihistamine (Loratadine).
What is the active ingredient?
Loratadine.
Who is the labeler?
NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 antihistamine?
8 other product NDCs are listed under this name. See all Loratadine antihistamine 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 antihistamine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralPadagis Israel Pharmaceuticals Ltd45802-65045802-0650-6545802-0650-7545802-0650-78+1 more
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralProficient Rx LP63187-60163187-0601-1063187-0601-1463187-0601-30+2 more
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.66267-65366267-0653-0766267-0653-1066267-0653-14+4 more
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-083650090-0836-0050090-0836-0450090-0836-05
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC43353-25943353-0259-0943353-0259-1843353-0259-60
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-34772789-0347-1472789-0347-2072789-0347-30+2 more
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-341468071-3414-03
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-38072789-0380-15

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/1TabletOralMajor Pharmaceuticals0904-6852
Berkley and Jensen Allergy ReliefloratadineLoratadine 10 mg/1TabletOralBJWC68391-314
LoratadineLoratadine 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-423
up and up allergy reliefloratadineLoratadine 10 mg/1TabletOralTarget Corporation11673-612
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralPadagis Israel Pharmaceuticals Ltd45802-650
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralKroger Company30142-612
allergy reliefloratadineLoratadine 10 mg/1TabletOralMeijer Distribution Inc41250-612
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralProficient Rx LP63187-601
members mark allergy reliefloratadineLoratadine 10 mg/1TabletOralSam's West Inc68196-711
Loratadine antihistamineloratadineLoratadine 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.66267-653
good neighbor pharmacy loratadineloratadineLoratadine 10 mg/1TabletOralAmerisource Bergen24385-471
good sense allergy reliefloratadineLoratadine 10 mg/1TabletOralL. Perrigo Company0113-0612
foster and thrive allergy reliefloratadineLoratadine 10 mg/1TabletOralStrategic Sourcing Services LLC70677-1022
basic care allergy reliefloratadineLoratadine 10 mg/1TabletOralAmazon.com Services LLC72288-612
goodnow allergy reliefloratadineLoratadine 10 mg/1TabletOralGobrands, Inc82501-0612
good sense allergy reliefloratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7048
good sense allergy reliefloratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7049
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

Showing 20 of 39.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

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
Loratadine antihistamine NDC 0615-8217 | Med-Code