Over-the-counter drug · ANDA

Childrens Loratadine (Loratadine) NDC 51672-2085

Loratadine 5 mg/5mL · Solution · Oral · Sun Pharmaceutical Industries, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51672-2085Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-2085Add 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
51672-2085-151672208501516722085011 BOTTLE in 1 CARTON (51672-2085-1) / 240 mL in 1 BOTTLEMarketed from Aug 20, 2004
51672-2085-451672208504516722085041 BOTTLE in 1 CARTON (51672-2085-4) / 60 mL in 1 BOTTLEMarketed from Aug 20, 2004
51672-2085-551672208505516722085051 BOTTLE in 1 CARTON (51672-2085-5) / 180 mL in 1 BOTTLEMarketed from Aug 20, 2004
51672-2085-851672208508516722085081 BOTTLE in 1 CARTON (51672-2085-8) / 120 mL in 1 BOTTLEMarketed from Aug 20, 2004

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
Generic name (nonproprietary)
loratadine
Active ingredients
Loratadine — 5 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076805
Marketing start
Listing expires
Identifiers
Product ID 51672-2085_5698c3d7-d47a-25e7-e063-6394a90a2d82SPL ID 5698c3d7-d47a-25e7-e063-6394a90a2d82SPL set ID 12c8066a-3429-481e-b63a-7ea2b439a170RxCUI 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

N451672208501 followed by a unit qualifier and the quantity

Package 51672-2085-01. 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 51672-2085

What is NDC 51672-2085?
51672-2085 is the product NDC for Childrens Loratadine (loratadine), Loratadine 5 mg/5mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Loratadine (Loratadine).
What is the active ingredient?
Loratadine.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Loratadine?
9 other product NDCs are listed under this name. See all Childrens 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 Childrens Loratadine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralTARGET CORPORATION11673-31011673-0310-30
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralSAFEWAY21130-96321130-0963-20
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralSAFEWAY21130-99921130-0999-20
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralTARGET CORPORATION11673-99711673-0997-30
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralCVS PHARMACY, INC69842-95469842-0954-30
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralOhm Laboratories Inc.51660-75451660-0754-31
Childrens LoratadineloratadineLoratadine 5 mg/1Tablet, ChewableOralCVS PHARMACY, INC69842-95369842-0953-20
Childrens LoratadineloratadineLoratadine 5 mg/5mLSolutionOralSun Pharmaceutical Industries, Inc.51672-207351672-2073-0451672-2073-0551672-2073-08
Childrens LoratadineloratadineLoratadine 5 mg/5mLSolutionOralStrategic Sourcing Services LLC62011-030562011-0305-01

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

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