NDC codes

FDA NDC Directory
Product NDC (as listed)0363-9603Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-9603Add 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
0363-9603-09003639603091 BOTTLE in 1 CARTON (0363-9603-09) / 30 TABLET in 1 BOTTLEMarketed from Jul 3, 2021

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
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208314
Marketing start
Listing expires
Identifiers
Product ID 0363-9603_0e58f8c9-b80a-4711-b5a0-e61954520d96SPL ID 0e58f8c9-b80a-4711-b5a0-e61954520d96SPL set ID c016aad8-df83-99b0-e053-2a95a90a49cfRxCUI 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

N400363960309 followed by a unit qualifier and the quantity

Package 00363-9603-09. 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 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
LoratadineLoratadine 10 mg/1TabletOralChain Drug Consortium, LLC68016-094
LoratadineLoratadine 10 mg/1TabletOralMcLane Company, Inc.57243-200
LoratadineLoratadine 10 mg/1TabletOralKROGER COMPANY30142-066
LoratadineLoratadine 10 mg/1TabletOralCardinal Health70000-0583
LoratadineLoratadine 10 mg/1TabletOralAurobindo Pharma Limited84386-119
LoratadineLoratadine 10 mg/1TabletOralMajor Pharmaceuticals0904-7426
LoratadineLoratadine 10 mg/1TabletOralAurohealth LLC58602-702
365 Whole Foods Market LoratadineloratadineLoratadine 10 mg/1TabletOralWhole Foods Market, Inc.42681-0053
LoratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7752
LoratadineLoratadine 10 mg/1TabletOralA-S Medication Solutions50090-7753
LoratadineLoratadine 10 mg/1TabletOralWinco Foods, LLC.67091-408
LoratadineLoratadine 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4103
LoratadineLoratadine 10 mg/1TabletOralAurohealth LLC58602-831
ALLERGY RELIEF 10mgloratadineLoratadine 10 mg/1TabletOralYYBA CORP73581-203
LoratadineLoratadine 10 mg/1TabletOralAurohealth LLC58602-847
LoratadineLoratadine 10 mg/1TabletOralYYBA CORP73581-229
Amazon Basic Care Allergy ReliefloratadineLoratadine 10 mg/1TabletOralAmazon.com Services LLC72288-452
CONTAC AllergyloratadineLoratadine 10 mg/1TabletOralVespyr Brands LLC71179-010
LoratadineLoratadine 10 mg/1TabletOralBluePoint Laboratories68001-438
LoratadineLoratadine 10 mg/1TabletOralCVS Pharmacy, Inc.69842-242

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