What is NDC 65131-116?

65131-116 is the product NDC for Broncochem Expectorant II, Acetaminophen 250 mg/10mL + 4 more ingredients syrup, listed with the FDA by LABORATORIO MAGNACHEM INTERNATIONAL SRL. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Broncochem Expectorant II (ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl).

What is the active ingredient?

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.

LABORATORIO MAGNACHEM INTERNATIONAL SRL, NDC labeler code 65131. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Broncochem Expectorant II?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Broncochem Expectorant II NDC 65131-116

NDC codes

FDA NDC Directory

Product NDC (as listed)65131-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65131-0116Add 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 NDC	11-digit (billing)	Package	Copy
65131-116-87	6513101168765131011687	1 BOTTLE, PLASTIC in 1 BOX (65131-116-87) / 120 mL in 1 BOTTLE, PLASTICMarketed from Dec 30, 2016

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): Broncochem Expectorant IISuffix: EXPECTORANT II
Generic name (nonproprietary): acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl
Active ingredients: Acetaminophen — 250 mg/10mLChlorpheniramine maleate — 4 mg/10mLDextromethorphan hydrobromide — 13.33 mg/10mLGuaifenesin — 200 mg/10mLPhenylephrine hydrochloride — 5 mg/10mL
Dosage form: Syrup
Route: Oral
Labeler: LABORATORIO MAGNACHEM INTERNATIONAL SRLNDC labeler code 65131
Product type: Over-the-counter drug
Marketing category: OTC monograph (not final)Application part343
Marketing start: Dec 30, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 65131-116_383c518a-2d0c-4346-894c-9e089094d612SPL ID 383c518a-2d0c-4346-894c-9e089094d612SPL set ID d0426469-9dd1-4bd1-b81e-69d33187daa2RxCUI 1743369UNII 362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJUPC 0805418116875
Pharmacologic class: Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist

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

N465131011687 followed by a unit qualifier and the quantity

Package 65131-0116-87. 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 Dec 19, 2016.

Indications (excerpt from the label)

Indications & Use Bronchial congestion Irritation of the respiratory passages Nasal congestion Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive Antitussive Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65131-116

What is NDC 65131-116?: 65131-116 is the product NDC for Broncochem Expectorant II, Acetaminophen 250 mg/10mL + 4 more ingredients syrup, listed with the FDA by LABORATORIO MAGNACHEM INTERNATIONAL SRL. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Broncochem Expectorant II (ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl).
What is the active ingredient?: Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.
Who is the labeler?: LABORATORIO MAGNACHEM INTERNATIONAL SRL, NDC labeler code 65131. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Broncochem Expectorant II?: 1 other product NDC are listed under this name. See all Broncochem Expectorant II 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 Broncochem Expectorant II NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Broncochem Expectorant IIacetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl	Acetaminophen 325 mg/10mL + 3 more ingredients	SyrupOral	LABORATORIO MAGNACHEM INTERNATIONAL SRL	65131-011	65131-0011-68

Other NDCs under part343

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

FDA NDC Directory listings under part343
Product	Strength	Form · route	Labeler	Product NDC
aspirin low dose enteric coatedaspirin	Aspirin 81 mg/1	Tablet, CoatedOral	Time-Cap Labs, Inc	49483-387
aspirin low dose enteric coatedaspirin	Aspirin 81 mg/1	TabletOral	Time-Cap Labs, Inc	49483-390
Acetaminophen Capletsacetaminophen	Acetaminophen 500 mg/1	TabletOral	Breeden Brothers, LLC	70729-001
Acetaminophen Capletsacetaminophen	Acetaminophen 500 mg/1	TabletOral	Breeden Brothers, LLC	70729-175
Geritrex Aspirinaspirin	Aspirin 325 mg/1	Tablet, CoatedOral	Geritrex LLC	54162-940
Pain Relief PMacetaminophen pm	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	TabletOral	Velocity Pharma	76168-119
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Velocity Pharma LLC	76168-120
CounterAct PMacetaminophen and diphenhydramine	Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1	TabletOral	Melaleuca, Inc.	54473-304
Acetaminophen	Acetaminophen 325 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-238
Aspirin	Aspirin 325 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-010
Aspirin	Aspirin 325 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-011
Acetaminophen	Acetaminophen 325 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-012
Apapacetaminophen	Acetaminophen 500 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-013
Apapacetaminophen	Acetaminophen 500 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-014
Aspirin	Aspirin 81 mg/1	TabletOral	Advance Pharmaceutical Inc.	17714-121
Extra Strength Acetaminophenacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	PuraCap Pharmaceutical LLC	51013-320
Doans Extra Strengthmagnesium salicylate	Magnesium salicylate 580 mg/1	TabletOral	Dr. Reddy's Laboratories Inc.	55741-224
Extra Strength Acetaminophenacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	CVS PHARMACY, INC.	69842-390
Childrens Tukol Acetaminophen Fever Reducer Pain Reduceracetaminophen	Acetaminophen 160 mg/5mL	LiquidOral	Genomma Lab USA, Inc.	50066-525
Apapacetaminophen	Acetaminophen 500 mg/1	TabletOral	Richmond Pharmaceuticals, Inc.	54738-040

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