Over-the-counter drug · ANDA

equate childrens allergy (loratadine) NDC 49035-611

Loratadine 5 mg/5mL · Solution · Oral · Wal-Mart Stores Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-611Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0611Add 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
49035-611-34490350611341 BOTTLE in 1 CARTON (49035-611-34) / 240 mL in 1 BOTTLEMarketed from Jun 22, 2018

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)
equate childrens allergy
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 075728
Marketing start
Listing expires
Identifiers
Product ID 49035-611_1266da85-f045-48b4-8b80-a9ec314b1282SPL ID 1266da85-f045-48b4-8b80-a9ec314b1282SPL set ID 5603d5e1-8d95-44b9-aceb-4bc37b162ab1RxCUI 692783UNII 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

N449035061134 followed by a unit qualifier and the quantity

Package 49035-0611-34. 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 075728

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

FDA NDC Directory listings under ANDA 075728
ProductStrengthForm · routeLabelerProduct NDC
leader childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralCardinal Health 110, LLC. dba Leader70000-0473
childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralKroger Company30142-723
childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralMeijer, Inc.41250-716
Childrens Loratadine OralloratadineLoratadine 5 mg/5mLSolutionOralAtlantic Biologicals17856-6767
good sense childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralL. Perrigo Company0113-1719
Childrens AllergyloratadineLoratadine 5 mg/5mLSolutionOralCVS Pharmacy69842-337
good neighbor pharmacy childrens loratadineloratadineLoratadine 5 mg/5mLSolutionOralAmerisource Bergen46122-787
Good Sense childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralNuCare Pharmaceuticals,Inc.68071-3904
topcare childrens allergyloratadineLoratadine 5 mg/5mLSolutionOralTopco Associates LLC36800-608
dg health childrens allergyloratadineLoratadine 5 mg/5mLSolutionOralDolgencorp, LLC55910-611
welby childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralAldi Inc64024-023
Good Sense childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralL. Perrigo Company0113-0671
childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralRite Aid Corporation11822-0620
Good Sense childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralPreferred Pharmaceuticals Inc.68788-8657
Childrens Loratadine OralloratadineLoratadine 5 mg/5mLSolutionOralA-S Medication Solutions50090-7516
Equaline Childrens Allergy ReliefloratadineLoratadine 5 mg/5mLSolutionOralUnited Natural Foods, Inc. dba UNFI41163-633
Childrens Loratadine OralloratadineLoratadine 5 mg/5mLSolutionOralMajor Pharmaceuticals0904-6767
Up And Up Childrens AllergyloratadineLoratadine 5 mg/5mLSolutionOralTarget Corporation82442-207
Childrens Allergy ReliefloratadineLoratadine 5 mg/5mLSolutionOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-611
basic care childrens allergy reliefloratadineLoratadine 5 mg/5mLSolutionOralAmazon.com Services LLC72288-511

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