NDC codes

FDA NDC Directory
Product NDC (as listed)51660-491Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51660-0491Add 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
51660-491-695166004916910 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51660-491-69)Marketed from Jan 15, 2020

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)
Loratadine and Pseudoephedrine
Generic name (nonproprietary)
loratadine and pseudoephedrine
Active ingredients
Loratadine — 10 mg/1Pseudoephedrine sulfate — 240 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076557
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 51660-491_39f4d9f5-7448-2a58-e063-6394a90a44b1SPL ID 39f4d9f5-7448-2a58-e063-6394a90a44b1SPL set ID bbe83464-a582-469f-8fac-f98e804d96feRxCUI 1117562UNII 7AJO3BO7QN, Y9DL7QPE6B
Pharmacologic class
alpha-Adrenergic Agonist

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

N451660049169 followed by a unit qualifier and the quantity

Package 51660-0491-69. 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: sneezing itchy, watery eyes runny nose itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076557

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

FDA NDC Directory listings under ANDA 076557
ProductStrengthForm · routeLabelerProduct NDC
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-5833
Loratadine and PseudoephedrineLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-1018
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralThe Kroger Company30142-724
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution, Inc.41250-724
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralStrategic Sourcing Services LLC62011-0071
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralStrategic Sourcing Services LLC62011-0071
Loratadine and PseudoephedrineLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralProficient Rx LP63187-305
Loratadine and PseudoephedrineLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralSportpharm LLC85766-048
Loratadine and PseudoephedrineLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralOhm Laboratories Inc.51660-724
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralHEB37808-427
Loratadine and PseudoephedrineLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-0725
KIRKLAND SIGNATURE ALLERCLEAR D 24 HR Extended Releaseloratadine and pseudoephedrine sulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralKirkland-COSTCO WHOLESALE COMPANY63981-724
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralSTRATEGIC SOURCING SERVICES49348-543
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralWAL-MART STORES, INC49035-488
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralAmerisource Bergen46122-167
Loratadine and Pseudoephedrine SulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralSafeway Inc.21130-724
Loratadine and PseudoephedrineLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralAMERISOURCE BERGEN46122-383
Allergy Relief-Dloratadine and pseudoephedrineLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy59779-726
Leader Allergy Relief D-24loratadine and pseudoephedrine sulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Film coated, Extended releaseOralCardinal Health70000-0162
Loratadine and Pseudoephedrineloratadine and pseudoephedrine sulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralRite Aid11822-9990

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