Over-the-counter drug · ANDA

dextromethorphan polistirex extended release (Dextromethorphan polistirex) NDC 45802-433

Dextromethorphan hydrobromide 30 mg/5mL · Suspension · Oral · Padagis Israel Pharmaceuticals Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)45802-433Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45802-0433Add 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
45802-433-2145802043321458020433211 BOTTLE in 1 CARTON (45802-433-21) / 89 mL in 1 BOTTLEMarketed from Sep 10, 2012

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

Generic name (nonproprietary)
dextromethorphan polistirex
Active ingredients
Dextromethorphan hydrobromide — 30 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091135
Marketing start
Listing expires
Other FDA classes
Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 45802-433_bab41dff-1e5a-44c4-884a-4625c10eda44SPL ID bab41dff-1e5a-44c4-884a-4625c10eda44
Pharmacologic class
Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

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

N445802043321 followed by a unit qualifier and the quantity

Package 45802-0433-21. 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 45802-433

What is NDC 45802-433?
45802-433 is the product NDC for dextromethorphan polistirex extended release, Dextromethorphan hydrobromide 30 mg/5mL suspension, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
dextromethorphan polistirex extended release (Dextromethorphan polistirex).
What is the active ingredient?
Dextromethorphan hydrobromide.
Who is the labeler?
Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for dextromethorphan polistirex extended release?
3 other product NDCs are listed under this name. See all dextromethorphan polistirex extended release 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 dextromethorphan polistirex extended release NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dextromethorphan Polistirex Extended-Releasedextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmneal Pharmaceuticals LLC65162-70065162-0700-7665162-0700-77
Dextromethorphan Polistirex Extended-Releasedextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmneal Pharmaceuticals LLC65162-79965162-0799-7665162-0799-77
dextromethorphan polistirex extended releasedextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralBryant Ranch Prepack72162-228172162-2281-02

Other NDCs under ANDA 091135

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

FDA NDC Directory listings under ANDA 091135
ProductStrengthForm · routeLabelerProduct NDC
good sense cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralL. Perrigo Company0113-0384
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralWalgreen Company0363-0494
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralMeijer Distribution Inc41250-958
basic care childrens cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmazon.com Services LLC72288-899
Good Neighbor Pharmacy Cough DM ERdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmerisource Bergen46122-141
childrens cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralWalgreen Company0363-0899
equaline cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralUnited Natural Foods, Inc. dba UNFI41163-384
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralWalgreen Company0363-0384
DG Health Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralDolgencorp, LLC55910-958
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralMeijer Distribution Inc41250-384
basic care cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmazon.com Services LLC72288-384
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralAmazon.com Services LLC72288-389
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralCVS Pharmacy59779-384
foster and thrive 12 hour cough reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralStrategic Sourcing Services LLC70677-1025
foster and thrive 12 hour cough reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralStrategic Sourcing Services LLC70677-1026
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralKroger Company30142-384
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralMajor Pharmaceuticals0904-6312
Good Sense Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralL. Perrigo Company0113-0958
Robitussin 12 Hour Cough Reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralHaleon US Holdings LLC0031-8755
12 Hr Relief Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-263

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