Over-the-counter drug · OTC MONOGRAPH DRUG

Pseudoephedrine Hydrochloride NDC 0904-6728

Pseudoephedrine hydrochloride 60 mg/1 · Tablet · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6728Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6728Add 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
0904-6728-460090467284630 TABLET in 1 BOTTLE (0904-6728-46)Marketed from Aug 29, 2019
0904-6728-52009046728521 BOTTLE in 1 CARTON (0904-6728-52) / 100 TABLET in 1 BOTTLEMarketed from Aug 26, 2019

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 — 60 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
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 0904-6728_5b76ffd1-7571-c41e-e063-6294a90a1bf3SPL ID 5b76ffd1-7571-c41e-e063-6294a90a1bf3
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

N400904672846 followed by a unit qualifier and the quantity

Package 00904-6728-46. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0904-6728

What is NDC 0904-6728?
0904-6728 is the product NDC for Pseudoephedrine Hydrochloride, Pseudoephedrine hydrochloride 60 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, 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?
Major Pharmaceuticals, NDC labeler code 0904. 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/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
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralDISCOUNT DRUG MART53943-20453943-0204-10

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
12 Hour Nasal Decongestant Extra Moisturizingnasal sprayOxymetazoline hydrochloride 50 mg/100mLLiquidNasalWinCo Foods LLC67091-377
12 Hour Original Nasal Decongestantnasal sprayOxymetazoline hydrochloride 50 mg/100mLLiquidNasalSheffield Pharmaceuticals LLC11527-140
12 Hour Original Nasal Decongestantnasal sprayOxymetazoline hydrochloride 50 mg/100mLLiquidNasalWinCo Foods LLC67091-378
24-7 Life BY 7-ELEVEN Nighttime Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate solutionDextromethorphan hydrobromide 30 mg/30mL + 2 more ingredientsSolutionOralLil' Drug Store products, Inc.66715-6416
24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointmentEucalyptus oil 1.2 g/100g + 2 more ingredientsOintmentTopicalLil' Drug Store Products, Inc.29485-6536
4 Way Fast Actingphenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/mLSprayNasalHaleon US Holdings LLC0067-2086
7 Select Maximum Strengthdextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLSolutionOral7-ELEVEN10202-740
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralHealth Pharma USA LLC71679-101
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgacetaminophen, dextromethorphan hbr and phenylephrine hclPhenylephrine hydrochloride 5 mg/1 + 2 more ingredientsCapsule, Liquid filledOralSoftgel Healthcare Private Limited35916-0188
Acetaminophen and Diphenhydramine citrateAcetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1TabletOralInvaTech Pharma Solutions LLC57631-010
Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hclAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralUnited Natural Foods, Inc. dba UNFI41163-228
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr—KitOralCVS Pharmacy, Inc51316-984
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClAcetaminophen 500 mg/1 + 2 more ingredientsTabletOralOPMX LLC69729-122
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClAcetaminophen 500 mg/1 + 2 more ingredientsTabletOralOPMX LLC69729-322
Acetaminophen, Dextromethorphan HBrAcetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1Capsule, Liquid filledOralNUVICARE LLC84324-036
Acetaminophen, Dextromethorphan HBr ,GuaifenesinGuaifenesin 200 mg/1 + 2 more ingredientsCapsule, Liquid filledOralSoftgel Healthcare Pvt Ltd35916-0184
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralSoftgel Healthcare Private Limited35916-0185
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate—KitOralCVS Pharmacy, Inc51316-609
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCLPhenylephrine hydrochloride 5 mg/1 + 3 more ingredientsCapsule, Liquid filledOralKroger Company41226-628
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine SuccinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralSoftgel Healthcare Private Limited35916-0154

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