Over-the-counter drug · ANDA

pseudoephedrine hydrochloride (Pseudoephedrine hcl) NDC 45802-107

Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Padagis Israel Pharmaceuticals Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)45802-107Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45802-0107Add 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
45802-107-52458020107524580201075210 BLISTER PACK in 1 CARTON (45802-107-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 24, 2014

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)
pseudoephedrine hydrochloride
Generic name (nonproprietary)
pseudoephedrine hcl
Active ingredients
Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075153
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 45802-107_a8ebb0c0-4ab7-4bf2-a8e3-09e62c3cdcd7SPL ID a8ebb0c0-4ab7-4bf2-a8e3-09e62c3cdcd7SPL set ID 4a4da1e6-2ad1-47f7-a9b3-7d845962ef3bRxCUI 1049154UNII 6V9V2RYJ8N
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

N445802010752 followed by a unit qualifier and the quantity

Package 45802-0107-52. 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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-107

What is NDC 45802-107?
45802-107 is the product NDC for pseudoephedrine hydrochloride (pseudoephedrine hcl), Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
pseudoephedrine hydrochloride (Pseudoephedrine HCl).
What is the active ingredient?
Pseudoephedrine hydrochloride.
Who is the labeler?
Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for pseudoephedrine hydrochloride?
27 other product NDCs are listed under this name. See all pseudoephedrine hydrochloride 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 pseudoephedrine hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 240 mg/1Tablet, Extended releaseOralWALGREEN CO.0363-661100363-6611-10
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 240 mg/1Tablet, Extended releaseOralAurohealth LLC58602-88458602-0884-2758602-0884-58
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-740900904-7409-15
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSTRATEGIC SOURCING SERVICES LLC70677-101970677-1019-0170677-1019-02
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1TabletOralCARDINAL HEALTH 110, LLC DBA LEADER70000-060170000-0601-01
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1TabletOralThe Kroger Company30142-96730142-0967-20
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 60 mg/1TabletOralMajor Pharmaceuticals0904-672800904-6728-4600904-6728-52
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 60 mg/1TabletOralA-S Medication Solutions50090-454650090-4546-01
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralHEB37808-00737808-0007-69
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 60 mg/1TabletOralMajor Pharmaceuticals0904-690700904-6907-06

All 28 pseudoephedrine hydrochloride NDCs

Other NDCs under ANDA 075153

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

FDA NDC Directory listings under ANDA 075153
ProductStrengthForm · routeLabelerProduct NDC
12 Hour Nasal Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy59779-703
CareOne Nasal and Sinus Decongestantpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralAmerican Sales Company41520-429
Equaline 12 Hour Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralUnited Natural Foods, Inc. dba UNFI41163-054
equate sinus 12 hourpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWal-Mart Stores Inc49035-508
good neighbor pharmacy nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralAmerisource Bergen24385-054
Good Sense Suphedrine 12 Hourpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0054
leader 12 hour nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0475
Leader 12 Hour Sinus Nasal Decongestantpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0735
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-809
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralHyVee Inc42507-054
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-054
Nasal Decongestant Dpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-3301
sinus 12 hourpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-2017
sinus and nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-616
sinus pressure and congestion relief maximum strengthpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralRite Aid Corporation11822-0650
Sudafed Sinus Congestion 12 Hourpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-4629
Sudafed Sinus Congestion 12 Hourpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-242
SudoGest 12 Hourpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-6754
topcare 12 hour decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-054

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