NDC codes

FDA NDC Directory
Product NDC (as listed)0121-0933Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-0933Add 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
0121-0933-040012109330400121093304118 mL in 1 BOTTLE (0121-0933-04)Marketed from Mar 3, 2022
0121-0933-160012109331600121093316473 mL in 1 BOTTLE (0121-0933-16)Marketed from Mar 3, 2022

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

Generic name (nonproprietary)
brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
Active ingredients
Brompheniramine maleate — 2 mg/5mLPseudoephedrine hydrochloride — 30 mg/5mLDextromethorphan hydrobromide — 10 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202940
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 0121-0933_44a05fe1-89fe-4252-b0b8-1ce678a4c6a7SPL ID 44a05fe1-89fe-4252-b0b8-1ce678a4c6a7SPL set ID 01ea6357-24dc-4056-9fd2-9e643650b91fRxCUI 1357010UNII IXA7C9ZN03, 6V9V2RYJ8N, 9D2RTI9KYH
Pharmacologic class
Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; 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

N400121093304 followed by a unit qualifier and the quantity

Package 00121-0933-04. 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)

INDICATIONS AND USAGE Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0933

What is NDC 0121-0933?
0121-0933 is the product NDC for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide, Brompheniramine maleate 2 mg/5mL + 2 more ingredients solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide (Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide).
What is the active ingredient?
Brompheniramine maleate, Pseudoephedrine hydrochloride, Dextromethorphan hydrobromide.
Who is the labeler?
PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide?
11 other product NDCs are listed under this name. See all Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide 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 Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralREMEDYREPACK INC.70518-452670518-4526-0070518-4526-0270518-4526-04
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideDextromethorphan hydrobromide 10 mg/5mL + 2 more ingredientsSyrupOralBIONPHARMA INC.69452-47869452-0478-5569452-0478-88
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralDr. Reddy's Labratories Inc.75907-20775907-0207-0475907-0207-16
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralChartwell RX, LLC62135-30262135-0302-2462135-0302-4762135-0302-48
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralChartwell Governmental & Specialty RX, LLC68999-30268999-0302-24
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralPadagis US LLC0574-110400574-1104-0400574-1104-16
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralA-S Medication Solutions50090-562550090-5625-00
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralProficient Rx LP63187-66463187-0664-04
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralBryant Ranch Prepack63629-861563629-8615-01
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan HydrobromideBrompheniramine maleate 2 mg/5mL + 2 more ingredientsSyrupOralBryant Ranch Prepack63629-861663629-8616-01

All 12 Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide NDCs

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