Over-the-counter drug · ANDA

Cough DM (Dextromethorphan polistirex) NDC 0363-0384

Dextromethorphan hydrobromide 30 mg/5mL · Suspension · Oral · Walgreen Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-0384Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-0384Add 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
0363-0384-21003630384211 BOTTLE in 1 CARTON (0363-0384-21) / 89 mL in 1 BOTTLEMarketed from Aug 28, 2012
0363-0384-28003630384281 BOTTLE in 1 CARTON (0363-0384-28) / 148 mL in 1 BOTTLEMarketed from Jul 16, 2013

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)
Cough DM
Generic name (nonproprietary)
dextromethorphan polistirex
Active ingredients
Dextromethorphan hydrobromide — 30 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Walgreen CompanyNDC labeler code 0363
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 0363-0384_4d041b9d-4324-41d7-a5c7-c46d90af4157SPL ID 4d041b9d-4324-41d7-a5c7-c46d90af4157SPL set ID c628923a-6771-4aba-9e2d-4795c9effb33RxCUI 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

N400363038421 followed by a unit qualifier and the quantity

Package 00363-0384-21. 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 0363-0384

What is NDC 0363-0384?
0363-0384 is the product NDC for Cough DM (dextromethorphan polistirex), Dextromethorphan hydrobromide 30 mg/5mL suspension, listed with the FDA by Walgreen Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cough DM (Dextromethorphan polistirex).
What is the active ingredient?
Dextromethorphan hydrobromide.
Who is the labeler?
Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cough DM?
18 other product NDCs are listed under this name. See all 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 Cough DM NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralAmazon.com Services LLC72288-38972288-0389-28
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmazon.com Services LLC72288-65272288-0652-28
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralSafeway21130-53821130-0538-21
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralKroger Company30142-49430142-0494-21
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralWalgreen Company0363-049400363-0494-28
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralHyVee Inc42507-49442507-0494-21
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralCVS Pharmacy59779-70959779-0709-2159779-0709-28
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralMeijer Distribution Inc41250-49441250-0494-28
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralPublix Super Markets Inc56062-38456062-0384-21
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralCVS Pharmacy59779-95859779-0958-2159779-0958-28

All 19 Cough DM NDCs

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
12 Hr Relief Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-263
12 hr relief cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-943
basic care childrens cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmazon.com Services LLC72288-899
basic care childrens cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmazon.com Services LLC72288-958
basic care cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmazon.com Services LLC72288-384
basic care cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralAmazon.com Services LLC72288-494
CareOne Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmerican Sales Company41520-384
CareOne Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmerican Sales Company41520-958
Childrens 12 Hr Cough Reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-429
childrens cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralWalgreen Company0363-0899
Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralHaleon US Holdings LLC0031-8725
Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralHaleon US Holdings LLC0031-8726
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralWalgreen Company0363-0494
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralMajor Pharmaceuticals0904-6312
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-6312
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralSafeway21130-538
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralKroger Company30142-384
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralKroger Company30142-494
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralH E B37808-384
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralMeijer Distribution Inc41250-384

Showing 20 of 39.

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