Over-the-counter drug · ANDA

TopCare Cough DM (Dextromethorphan polistirex) NDC 36800-494

Dextromethorphan hydrobromide 30 mg/5mL · Suspension, Extended release · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-494Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0494Add 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
36800-494-2136800049421368000494211 BOTTLE in 1 CARTON (36800-494-21) / 89 mL in 1 BOTTLEMarketed from Jul 30, 2015
36800-494-2836800049428368000494281 BOTTLE in 1 CARTON (36800-494-28) / 148 mL in 1 BOTTLEMarketed from Aug 8, 2024

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)
TopCare Cough DM
Generic name (nonproprietary)
dextromethorphan polistirex
Active ingredients
Dextromethorphan hydrobromide — 30 mg/5mL
Dosage form
Suspension, Extended release
Route
Oral
Labeler
Topco Associates LLCNDC labeler code 36800
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 36800-494_2dabf072-f553-4228-8990-58af55f66b32SPL ID 2dabf072-f553-4228-8990-58af55f66b32SPL set ID 490f695c-e60f-43db-b3f3-a9ffbb2906ddRxCUI 1373045UNII 9D2RTI9KYH
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

N436800049421 followed by a unit qualifier and the quantity

Package 36800-0494-21. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses temporarily relieves • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the impulse to cough to help you get to sleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-494

What is NDC 36800-494?
36800-494 is the product NDC for TopCare Cough DM (dextromethorphan polistirex), Dextromethorphan hydrobromide 30 mg/5mL suspension, extended release, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TopCare Cough DM (Dextromethorphan polistirex).
What is the active ingredient?
Dextromethorphan hydrobromide.
Who is the labeler?
Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TopCare Cough DM?
1 other product NDC are listed under this name. See all TopCare Cough DM 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 TopCare Cough DM NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Topcare Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralTopco Associates LLC36800-55236800-0552-2136800-0552-28

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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