NDC codes

FDA NDC Directory
Product NDC (as listed)68071-4451Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-4451Add 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
68071-4451-46807144510468071445104120 mL in 1 BOX (68071-4451-4)Marketed from May 25, 2018

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 — 5 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077421
Marketing start
Listing expires
Identifiers
Product ID 68071-4451_1a8d3388-fe39-f764-e063-6394a90aec08SPL ID 1a8d3388-fe39-f764-e063-6394a90aec08SPL set ID 6d0c0948-9288-9bb8-e053-2a91aa0abf3aRxCUI 692783UNII 7AJO3BO7QNUPC 0368071445145

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

N468071445104 followed by a unit qualifier and the quantity

Package 68071-4451-04. 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 68071-4451

What is NDC 68071-4451?
68071-4451 is the product NDC for Loratadine, Loratadine 5 mg/5mL solution, listed with the FDA by NuCare Pharmaceuticals,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?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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?
107 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 108 Loratadine NDCs

Other NDCs under ANDA 077421

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

FDA NDC Directory listings under ANDA 077421
ProductStrengthForm · routeLabelerProduct NDC
LoratadineLoratadine 5 mg/5mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-0557
LoratadineLoratadine 5 mg/5mLSolutionOralA-S Medication Solutions50090-1454
LoratadineLoratadine 5 mg/5mLSolutionOralLannett Company, Inc.54838-554
LoratadineLoratadine 5 mg/5mLSolutionOralLannett Company, Inc.54838-558

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