Over-the-counter drug · ANDA

Signature Care Cough Relief (dextromethorphan polistirex) NDC 21130-520

Dextromethorphan hydrobromide 30 mg/5mL · Suspension, Extended release · Oral · Safeway

NDC codes

FDA NDC Directory
Product NDC (as listed)21130-520Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21130-0520Add 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
21130-520-21211300520211 BOTTLE in 1 CARTON (21130-520-21) / 89 mL in 1 BOTTLEMarketed from Jul 8, 2021

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)
Signature Care Cough Relief
Generic name (nonproprietary)
dextromethorphan polistirex
Active ingredients
Dextromethorphan hydrobromide — 30 mg/5mL
Dosage form
Suspension, Extended release
Route
Oral
Labeler
Safeway
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 21130-520_5d7aec7b-44b4-4cdc-8361-fa19bdb74c65SPL ID 5d7aec7b-44b4-4cdc-8361-fa19bdb74c65SPL set ID f95d0519-e96b-45fe-974c-8fe6b9b8c88cRxCUI 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

N421130052021 followed by a unit qualifier and the quantity

Package 21130-0520-21. 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)

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
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralHyVee Inc42507-384
CareOne Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmerican Sales Company41520-384
foster and thrive 12 hour cough reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralStrategic Sourcing Services LLC70677-1026
up and up 12 hour cough reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralTarget Corporation11673-114
foster and thrive 12 hour cough reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralStrategic Sourcing Services LLC70677-1025
Robitussin 12 Hour Cough Reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralHaleon US Holdings LLC0031-8755
DG Health Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralDolgencorp Inc55910-384
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralMajor Pharmaceuticals0904-6312
TopCare Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralTopco Associates LLC36800-494
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralHyVee Inc42507-494
DG Health Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralDolgencorp, LLC55910-958
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralSafeway21130-538
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralAmazon.com Services LLC72288-652
cough dmdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-6312
Robitussin 12 Hour Cough Reliefdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralHaleon US Holdings LLC0031-8753
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralWalgreen Company0363-0494
Topcare Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralTopco Associates LLC36800-552
Good Sense Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralL. Perrigo Company0113-0958
12 Hr Relief Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-263
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspensionOralCVS Pharmacy59779-384

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