Over-the-counter drug · OTC MONOGRAPH DRUG

pseudoephedrine hydrochloride (Pseudoephedrine hcl) NDC 71205-197

Pseudoephedrine hydrochloride 30 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-197Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0197Add 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
71205-197-247120501972424 BLISTER PACK in 1 CARTON (71205-197-24) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 1, 2019

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 — 30 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 71205-197_6236aedc-30e4-4415-b866-47a44a5da5b0SPL ID 6236aedc-30e4-4415-b866-47a44a5da5b0SPL set ID a910320b-0585-40bd-928c-0406346281d0RxCUI 1049160UNII 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

N471205019724 followed by a unit qualifier and the quantity

Package 71205-0197-24. 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 sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-197

What is NDC 71205-197?
71205-197 is the product NDC for pseudoephedrine hydrochloride (pseudoephedrine hcl), Pseudoephedrine hydrochloride 30 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. 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?
Proficient Rx LP, NDC labeler code 71205. 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 M 012

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

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
Cold and Flu HBPacetaminophen, chlorpheniramine maleateAcetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1Tablet, Film coatedOralWALMART INC.79903-120
Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate—KitWALMART INC.79903-417
Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsLiquidOralP & L Development, LLC49580-0343
Sinus Severeacetaminophen, guaifenesin, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsTablet, Film coatedOralL.N.K. International, Inc.50844-572
SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsTablet, Film coatedOralKenvue Brands LLC50580-450
Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hclDextromethorphan hydrobromide 20 mg/30mL + 3 more ingredientsLiquidOralTARGET CORPORATION11673-828
Freegells Cough Drops Menthol Cherry 30ctmentholLevomenthol 5.8 mg/1LozengeOralRL Albert & Son Inc.83002-040
SanatosmentholMenthol 5.4 mg/1LozengeOralPharmadel LLC55758-518
Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralVALU MERCHANDISERS COMPANY63941-173
Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hclDexbrompheniramine maleate 1 mg/mL + 2 more ingredientsSyrupOralDextrum Laboratories, Inc65852-020
Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsuleOralChain Drug Consortium, LLC68016-878
Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsTablet, CoatedOralHARRIS TEETER72036-274
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hclAcetaminophen 1000 mg/30mL + 3 more ingredientsSyrupOralHaleon US Holdings LLC0067-0114
Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin—KitWALMART INC.79903-414
Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesiAcetaminophen 650 mg/20mL + 2 more ingredientsLiquidOralMEIJER DISTRIBUTION INC79481-6308
Menthol Cough DropsmentholMenthol 5.8 mg/1PastilleOralTarget Corporation Inc.82442-001
adult dm max cough and chest congestiondextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLSolutionOralMeijer Distribution Inc41250-261
Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochlorideChlorpheniramine maleate 2 mg/5mL + 2 more ingredientsLiquidOralAdvanced Generic Corporation45737-250
Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1TabletOralAMERISOURCE BERGEN46122-829
Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl—KitL.N.K. International, Inc.50844-529

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