Over-the-counter drug · ANDA

Leader Allergy Relief D12 (Loratadine, pseudoephedrine sulfate) NDC 70000-0504

Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Film coated, Extended release · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0504Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0504Add 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
70000-0504-1700000504017000005040110 BLISTER PACK in 1 CARTON (70000-0504-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 9, 2020
70000-0504-2700000504027000005040220 BLISTER PACK in 1 CARTON (70000-0504-2) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 9, 2020
70000-0504-3700000504037000005040330 BLISTER PACK in 1 CARTON (70000-0504-3) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 9, 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 D12
Generic name (nonproprietary)
loratadine, pseudoephedrine sulfate
Active ingredients
Loratadine — 5 mg/1Pseudoephedrine sulfate — 120 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076050
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 70000-0504_ae900734-0351-4a74-98a0-4af543e1882dSPL ID ae900734-0351-4a74-98a0-4af543e1882dSPL set ID 98bd6186-2bd2-4f46-99df-f509bb00e03aRxCUI 1242399UNII 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

N470000050401 followed by a unit qualifier and the quantity

Package 70000-0504-01. 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 • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • 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)

About NDC 70000-0504

What is NDC 70000-0504?
70000-0504 is the product NDC for Leader Allergy Relief D12, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, film coated, extended release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader Allergy Relief D12 (Loratadine, Pseudoephedrine sulfate).
What is the active ingredient?
Loratadine, Pseudoephedrine sulfate.
Who is the labeler?
Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leader Allergy Relief D12?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 076050

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

FDA NDC Directory listings under ANDA 076050
ProductStrengthForm · routeLabelerProduct NDC
Alavert Allergy and Congestion D-12 hourloratadine and pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralFoundation Consumer Brands80070-100
Allergy and Congestion Reliefloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-2007
allergy and nasal congestionloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralKroger Company30142-850
allergy relief dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-954
allergy relief dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-555
allergy relief d 12loratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-7023
allergy relief d 12loratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy69842-641
equate allergy and congestion reliefloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralWal-Mart Stores Inc49035-643
foster and thrive allergy D 12 hourloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralStrategic Sourcing Services LLC70677-1024
good neighbor pharmacy loratadine dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralAmerisource Bergen46122-455
kirkland signature allerclear d 12 hrloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralCostco Wholesale Company63981-723
loratadine Dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralPadagis Israel Pharmaceuticals Ltd45802-122
loratadine Dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralSportpharm LLC85766-047
perrigo allergy dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-7777
signature care allergy and congestion reliefloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralSafeway21130-482
topcare allergy and congestion reliefloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-611

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