NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0583Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0583Add 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
70000-0583-170000058301700000583012 BLISTER PACK in 1 CARTON (70000-0583-1) / 10 TABLET in 1 BLISTER PACKMarketed from Aug 30, 2021
70000-0583-270000058302700000583021 BOTTLE in 1 CARTON (70000-0583-2) / 30 TABLET in 1 BOTTLEMarketed from Jun 14, 2024

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)
Loratadine
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Cardinal HealthNDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208314
Marketing start
Listing expires
Identifiers
Product ID 70000-0583_57c1fc35-94df-4613-bfec-97f1dd995df0SPL ID 57c1fc35-94df-4613-bfec-97f1dd995df0SPL set ID c96dd1c9-85a0-0792-e053-2a95a90a2264RxCUI 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

N470000058301 followed by a unit qualifier and the quantity

Package 70000-0583-01. 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 70000-0583

What is NDC 70000-0583?
70000-0583 is the product NDC for Loratadine, Loratadine 10 mg/1 tablet, listed with the FDA by Cardinal Health. It has 2 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?
Cardinal Health, NDC labeler code 70000. 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 208314

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

FDA NDC Directory listings under ANDA 208314
ProductStrengthForm · routeLabelerProduct NDC
365 Whole Foods Market LoratadineloratadineLoratadine 10 mg/1TabletOralWhole Foods Market, Inc.42681-0053
ALLERGY RELIEF 10mgloratadineLoratadine 10 mg/1TabletOralYYBA CORP73581-203
Amazon Basic Care Allergy ReliefloratadineLoratadine 10 mg/1TabletOralAmazon.com Services LLC72288-452
CONTAC AllergyloratadineLoratadine 10 mg/1TabletOralVespyr Brands LLC71179-010
LoratadineLoratadine 10 mg/1TabletOralWALGREEN CO.0363-9603
LoratadineLoratadine 10 mg/1TabletOralMajor Pharmaceuticals0904-7426
LoratadineLoratadine 10 mg/1TabletOralKROGER COMPANY30142-066
LoratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7752
LoratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7753
LoratadineLoratadine 10 mg/1TabletOralMcLane Company, Inc.57243-200
LoratadineLoratadine 10 mg/1TabletOralAurohealth LLC58602-702
LoratadineLoratadine 10 mg/1TabletOralAurohealth LLC58602-831
LoratadineLoratadine 10 mg/1TabletOralAurohealth LLC58602-847
LoratadineLoratadine 10 mg/1TabletOralWinco Foods, LLC.67091-408
LoratadineLoratadine 10 mg/1TabletOralBluePoint Laboratories68001-438
LoratadineLoratadine 10 mg/1TabletOralChain Drug Consortium, LLC68016-094
LoratadineLoratadine 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4103
LoratadineLoratadine 10 mg/1TabletOralCVS Pharmacy, Inc.69842-242
LoratadineLoratadine 10 mg/1TabletOralYYBA CORP73581-229
LoratadineLoratadine 10 mg/1TabletOralAurobindo Pharma Limited84386-119

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