Over-the-counter drug · ANDA

Leader Allergy Relief D-24 NDC 70000-0162

loratadine and pseudoephedrine sulfate · Loratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1 · Tablet, Film coated, Extended release · Oral · Cardinal Health

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0162Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0162Add 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
70000-0162-17000001620110 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-1)Marketed from Jan 15, 2020
70000-0162-27000001620215 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-2)Marketed from Jan 15, 2020

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)
Leader Allergy Relief D-24
Generic name (nonproprietary)
loratadine and pseudoephedrine sulfate
Active ingredients
Loratadine — 10 mg/1Pseudoephedrine sulfate — 240 mg/1
Dosage form
Tablet, Film coated, 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 70000-0162_2aa29226-da73-4113-9dbd-ed13b345464dSPL ID 2aa29226-da73-4113-9dbd-ed13b345464dSPL set ID f1bcd2aa-e8cd-4364-87b4-c544537cdb50RxCUI 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

N470000016201 followed by a unit qualifier and the quantity

Package 70000-0162-01. 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: ■ 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 PseudoephedrineLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralOhm Laboratories Inc.51660-491
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
Loratadine and Pseudoephedrineloratadine and pseudoephedrine sulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralRite Aid11822-9990

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