Over-the-counter drug · ANDA

allergy relief d (Loratadine, pseudoephedrine sulfate) NDC 56062-555

Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Film coated, Extended release · Oral · Publix Super Markets Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)56062-555Labeler and product segments. Claims need a package NDC.
Product NDC at billing width56062-0555Add 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
56062-555-465606205554610 BLISTER PACK in 1 CARTON (56062-555-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 23, 2018
56062-555-605606205556020 BLISTER PACK in 1 CARTON (56062-555-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 23, 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)
allergy relief d
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
Publix Super Markets IncNDC labeler code 56062
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 56062-555_80e35c89-92c7-4256-8129-4e727f864e03SPL ID 80e35c89-92c7-4256-8129-4e727f864e03SPL set ID 8209d7d5-4ecc-4170-ba50-5917bd8c46d4RxCUI 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

N456062055546 followed by a unit qualifier and the quantity

Package 56062-0555-46. 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 56062-555

What is NDC 56062-555?
56062-555 is the product NDC for allergy relief d, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, film coated, extended release, listed with the FDA by Publix Super Markets Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
allergy relief d (Loratadine, Pseudoephedrine sulfate).
What is the active ingredient?
Loratadine, Pseudoephedrine sulfate.
Who is the labeler?
Publix Super Markets Inc, NDC labeler code 56062. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for allergy relief d?
14 other product NDCs are listed under this name. See all allergy relief d 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 allergy relief d NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Allergy Relief-Dloratadine and pseudoephedrine sulfatePseudoephedrine sulfate 240 mg/1; Loratadine 10 mg/1Tablet, Extended releaseOralHEB37808-78737808-0787-0737808-0787-35
Allergy Relief Dloratadine, pseudoephedrine sulfateLoratadine 10 mg/1; Pseudoephedrine sulfate 240 mg/1Tablet, Extended releaseOralWalgreen Company0363-201000363-2010-22
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC70677-102070677-1020-0170677-1020-02
Allergy relief-Dcetirizine hydrochloride and pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralRITE AID11822-999411822-9994-0111822-9994-02
allergy relief-Dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralRite Aid Corporation11822-300911822-3009-00
Allergy Relief Dchlorpheniramine maleate, pseudoephedrine hclChlorpheniramine maleate 4 mg/1; Pseudoephedrine hydrochloride 60 mg/1TabletOralWalgreen Company0363-111000363-1110-22
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralH E B37808-65137808-0651-5337808-0651-62
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy69842-41569842-0415-5369842-0415-62
allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-14756062-0147-5356062-0147-62
Allergy Relief-Dcetirizine hydrochloride and pseudoephedrine hydrochlorideCetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralCVS PHARMACY69842-99469842-0994-1269842-0994-24

All 15 allergy relief d NDCs

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 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
Leader Allergy Relief D12loratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0504
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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