NDC codes

FDA NDC Directory
Product NDC (as listed)51672-2131Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-2131Add 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
51672-2131-1516722131011 BOTTLE in 1 CARTON (51672-2131-1) / 240 mL in 1 BOTTLEMarketed from Mar 17, 2017
51672-2131-4516722131041 BOTTLE in 1 CARTON (51672-2131-4) / 60 mL in 1 BOTTLEMarketed from Mar 17, 2017
51672-2131-8516722131081 BOTTLE in 1 CARTON (51672-2131-8) / 120 mL in 1 BOTTLEMarketed from Mar 17, 2017

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)
Childrens Loratadine Sugar FreeSuffix: Sugar Free
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 5 mg/5mL
Dosage form
Solution
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076805
Marketing start
Listing expires
Identifiers
Product ID 51672-2131_5a4df9e7-54bd-7382-e063-6394a90aa38dSPL ID 5a4df9e7-54bd-7382-e063-6394a90aa38dSPL set ID 58eaab62-ac36-4080-8ded-9b472dddc617RxCUI 692783UNII 7AJO3BO7QNUPC 0351672213183

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

N451672213101 followed by a unit qualifier and the quantity

Package 51672-2131-01. 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)

Other NDCs under ANDA 076805

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

FDA NDC Directory listings under ANDA 076805
ProductStrengthForm · routeLabelerProduct NDC
Childrens Loratadine Sugar FreeloratadineLoratadine 5 mg/5mLSolutionOralSTRATEGIC SOURCING SERVICES LLC70677-1058
Good Neighbor Pharmacy Childrens LoratadineloratadineLoratadine 5 mg/5mLSolutionOralAmerisourceBergen24385-531
LoratadineLoratadine 5 mg/5mLSolutionOralSTRATEGIC SOURCING SERVICES LLC70677-1057
Childrens LoratadineloratadineLoratadine 5 mg/5mLSolutionOralStrategic Sourcing Services LLC62011-0305
Childrens LoratadineloratadineLoratadine 5 mg/5mLSolutionOralSun Pharmaceutical Industries, Inc.51672-2073
Childrens LoratadineloratadineLoratadine 5 mg/5mLSolutionOralSun Pharmaceutical Industries, Inc.51672-2085
childrens allergyloratadineLoratadine 5 mg/5mLSolutionOralPublix Super Markets Inc56062-092
Sunmark childrens loratadineloratadineLoratadine 5 mg/5mLSolutionOralStrategic Sourcing Services LLC49348-636
LoratadineLoratadine 5 mg/5mLSolutionOralCardinal Health, 110 dba LEADER70000-0125
Childrens Loratadine Sugar FreeloratadineLoratadine 5 mg/5mLSolutionOralPreferred Pharmaceuticals Inc.68788-8286
Childrens Loratadine Sugar FreeloratadineLoratadine 5 mg/5mLSolutionOralWalgreen Company0363-2131
Childrens Loratadine Sugar FreeloratadineLoratadine 5 mg/5mLSolutionOralH E B37808-131
Childrens Loratadine Sugar FreeloratadineLoratadine 5 mg/5mLSolutionOralAmerican Sales Company41520-131

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