Over-the-counter drug · ANDA

equate allergy and congestion relief NDC 49035-643

loratadine, pseudoephedrine sulfate · Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 · Tablet, Film coated, Extended release · Oral · Wal-Mart Stores Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-643Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0643Add 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
49035-643-464903506434610 BLISTER PACK in 1 CARTON (49035-643-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 24, 2020
49035-643-604903506436020 BLISTER PACK in 1 CARTON (49035-643-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 24, 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)
equate allergy and congestion relief
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
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 49035-643_7acb58ab-357f-413d-bb57-2dc33ef0f709SPL ID 7acb58ab-357f-413d-bb57-2dc33ef0f709SPL set ID 306e8736-b27f-4445-b613-3e5b609f8d42RxCUI 1242399UNII 7AJO3BO7QN, Y9DL7QPE6BUPC 0681131355476
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

N449035064346 followed by a unit qualifier and the quantity

Package 49035-0643-46. 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)

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
signature care allergy and congestion reliefloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralSafeway21130-482
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
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
Leader Allergy Relief D12loratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0504
allergy and nasal congestionloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralKroger Company30142-850
loratadine Dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralSportpharm LLC85766-047
kirkland signature allerclear d 12 hrloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralCostco Wholesale Company63981-723
topcare allergy and congestion reliefloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-611
allergy relief dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-954
loratadine Dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralPadagis Israel Pharmaceuticals Ltd45802-122
good neighbor pharmacy loratadine dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralAmerisource Bergen46122-455
Allergy and Congestion Reliefloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-2007
allergy relief dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-555
Allergy Relief Dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralRite Aid Corporation11822-1055
allergy relief d 12loratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy69842-641
allergy relief d 12loratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-7023
perrigo allergy dloratadine, pseudoephedrine sulfateLoratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-7777

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