Over-the-counter drug · ANDA

Pseudoephedrine Hydrochloride NDC 0363-0204

Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · Walgreen Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0204Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0204Add 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
0363-0204-200036302042020 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-20)Marketed from Jan 16, 2019
0363-0204-690036302046910 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0363-0204-69)Marketed from Apr 28, 2006

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Film coated, Extended release
Route
Oral
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 0363-0204_d03cb6bb-f193-4cc7-807f-209cdea81efcSPL ID d03cb6bb-f193-4cc7-807f-209cdea81efcSPL set ID e33d6ca8-7b3c-42ad-85d3-3302a949501eRxCUI 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

N400363020420 followed by a unit qualifier and the quantity

Package 00363-0204-20. 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)

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
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSTRATEGIC SOURCING SERVICES LLC70677-1019
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralChain Drug Consortium, LLC68016-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy59779-204
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, 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 coatedOralSportpharm LLC85766-050
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1TabletOralCARDINAL HEALTH 110, LLC DBA LEADER70000-0601
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1TabletOralThe Kroger Company30142-967
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5554
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralHEB37808-007
12 Hour Nasal Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralCARDINAL HEALTH70000-0656
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralDISCOUNT DRUG MART53943-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralSafeway Inc.21130-204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7409
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSAM'S WEST INC68196-204
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralStrategic Sourcing Services70677-0001

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