Over-the-counter drug · ANDA

Pseudoephedrine hydrochloride NDC 53943-204

Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · DISCOUNT DRUG MART

NDC codes

FDA NDC Directory
Product NDC (as listed)53943-204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0204Add 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
53943-204-1053943020410539430204101 BLISTER PACK in 1 CARTON (53943-204-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 2, 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)
Pseudoephedrine hydrochloride
Generic name (nonproprietary)
pseudoephedrine hydrochloride
Active ingredients
Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
DISCOUNT DRUG MARTNDC labeler code 53943
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077442
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 53943-204_0ca9df6b-df27-4658-8c9d-751ceb61d820SPL ID 0ca9df6b-df27-4658-8c9d-751ceb61d820SPL set ID 7668ad20-1ca7-4d93-b3a3-03cfde141f86RxCUI 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

N453943020410 followed by a unit qualifier and the quantity

Package 53943-0204-10. 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 53943-204

What is NDC 53943-204?
53943-204 is the product NDC for Pseudoephedrine hydrochloride, Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by DISCOUNT DRUG MART. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pseudoephedrine hydrochloride.
What is the active ingredient?
Pseudoephedrine hydrochloride.
Who is the labeler?
DISCOUNT DRUG MART, NDC labeler code 53943. 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 077442

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

FDA NDC Directory listings under ANDA 077442
ProductStrengthForm · routeLabelerProduct NDC
12 Hour Nasal Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralCARDINAL HEALTH70000-0656
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralStrategic Sourcing Services70677-0001
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-0204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7409
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralSafeway Inc.21130-204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1TabletOralThe Kroger Company30142-967
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralHEB37808-007
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5554
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralOhm Laboratories Inc.51660-204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralOhm Laboratories Inc.51660-492
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy59779-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC62011-0306
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralChain Drug Marketing Association Inc.63868-143
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralChain Drug Consortium, LLC68016-204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSAM'S WEST INC68196-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1TabletOralCARDINAL HEALTH 110, LLC DBA LEADER70000-0601
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSTRATEGIC SOURCING SERVICES LLC70677-1019
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSportpharm LLC85766-050

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