Over-the-counter drug · ANDA

Good Neighbor Pharmacy Cough DM ER (Dextromethorphan polistirex) NDC 46122-141

Dextromethorphan hydrobromide 30 mg/5mL · Suspension · Oral · Amerisource Bergen

NDC codes

FDA NDC Directory
Product NDC (as listed)46122-141Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46122-0141Add 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
46122-141-2146122014121461220141211 BOTTLE in 1 CARTON (46122-141-21) / 89 mL in 1 BOTTLEMarketed from Aug 30, 2012
46122-141-2546122014125461220141251 BOTTLE in 1 CARTON (46122-141-25) / 148 mL in 1 BOTTLEMarketed from Aug 2, 2013

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)
Good Neighbor Pharmacy Cough DM ER
Generic name (nonproprietary)
dextromethorphan polistirex
Active ingredients
Dextromethorphan hydrobromide — 30 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Amerisource BergenNDC labeler code 46122
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 46122-141_12c96da8-1f21-416b-aa04-54405e71afc6SPL ID 12c96da8-1f21-416b-aa04-54405e71afc6
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

N446122014121 followed by a unit qualifier and the quantity

Package 46122-0141-21. 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 46122-141

What is NDC 46122-141?
46122-141 is the product NDC for Good Neighbor Pharmacy Cough DM ER, Dextromethorphan hydrobromide 30 mg/5mL suspension, listed with the FDA by Amerisource Bergen. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Good Neighbor Pharmacy Cough DM ER (Dextromethorphan polistirex).
What is the active ingredient?
Dextromethorphan hydrobromide.
Who is the labeler?
Amerisource Bergen, NDC labeler code 46122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Good Neighbor Pharmacy Cough DM ER?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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
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
Cough DMdextromethorphan polistirexDextromethorphan hydrobromide 30 mg/5mLSuspension, Extended releaseOralMeijer Distribution Inc41250-494

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