NDC codes

FDA NDC Directory
Product NDC (as listed)69848-019Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69848-0019Add 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
69848-019-1069848001910100 TABLET in 1 BOTTLE (69848-019-10)Marketed from Jul 26, 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)
Loratadine
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
GRANULES USA, INC.NDC labeler code 69848
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210722
Marketing start
Listing expires
Identifiers
Product ID 69848-019_469099a1-3de4-d107-e063-6294a90adf16SPL ID 469099a1-3de4-d107-e063-6294a90adf16SPL set ID c3c9bc45-7ed5-abf4-e053-2995a90a40ffRxCUI 311372UNII 7AJO3BO7QNUPC 0813874020032

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

N469848001910 followed by a unit qualifier and the quantity

Package 69848-0019-10. 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 69848-019

What is NDC 69848-019?
69848-019 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by GRANULES USA, INC.. It has 1 package NDC, 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?
GRANULES USA, INC., NDC labeler code 69848. 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?
108 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 109 Loratadine NDCs

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
24 / 7 Life Non-Drowsy Allergy Reliefloratadine tabletLoratadine 10 mg/1TabletOralLil' Drug Store Products, Inc.29485-8156
LoratadineLoratadine 10 mg/1TabletOralSpirit Pharmaceuticals LLC68210-4110
ValuMeds Allergy ReliefloratadineLoratadine 10 mg/1TabletOralCabinet Health P.B.C.82725-1042
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralGrocery Outlet, Inc85828-193
24 / 7 Life Non-Drowsy Allergy Reliefloratadine tabletLoratadine 10 mg/1TabletOralLil' Drug Store Products, Inc.29485-5515
McKesson LoradatinelorataindeLoratadine 10 mg/1TabletOralMcKesson Medical Surgical68599-4785
Medi-First Plus Allery ReliefloratadineLoratadine 10 mg/1TabletOralUnifirst First Aid Corporation47682-912
LoratadineLoratadine 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3596
LoratadineLoratadine 10 mg/1TabletOralAdvanced Rx LLC80513-711
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralAAA PHARMACEUTICAL, INC.57344-193
LoratadineLoratadine 10 mg/1TabletOralGranules Pharmaceuticals Inc.70010-162
XL - 3 AllergyLoratadine 10 mg/1TabletOralSelder, S.A. de C.V.63654-415
First Aid Direct Allergy Reliefloratadine tabletsLoratadine 10 mg/1TabletOralCintas Corporation42961-120
LoratadineLoratadine 10 mg/1TabletOralGranules India Limited62207-787
LoratadineLoratadine 10 mg/1TabletOralBryant Ranch Prepack71335-2431
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralAllegiant Health69168-414
LoratadineLoratadine 10 mg/1TabletOralAMZ789 LLC73629-003
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralFSA STORE INC.81522-393
Green Guard 24 Hour Allergy ReliefloratadineLoratadine 10 mg/1TabletOralUnifirst First Aid Corporation47682-117
Allergy ReliefloratadineLoratadine 10 mg/1TabletOralHARRIS TEETER72036-193

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