Over-the-counter drug · ANDA

Pseudoephedrine Hydrochloride NDC 62011-0306

Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · STRATEGIC SOURCING SERVICES LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)62011-0306Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62011-0306Add 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
62011-0306-16201103060110 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (62011-0306-1)Marketed from Feb 20, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
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 62011-0306_166eaa7e-a180-438e-88b9-6b31bc794b7bSPL ID 166eaa7e-a180-438e-88b9-6b31bc794b7bSPL set ID 918b2a90-532b-4358-bdff-9ad48c167a7eRxCUI 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

N462011030601 followed by a unit qualifier and the quantity

Package 62011-0306-01. 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, 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
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-0204

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