What is NDC 36800-219?

36800-219 is the product NDC for Topcare Mucus DM, Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 tablet, 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 Mucus DM (Dextromethorphan hydrobromide, guaifenesin).

What is the active ingredient?

Dextromethorphan hydrobromide, Guaifenesin.

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 Mucus DM?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topcare Mucus DM NDC 36800-219 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-219Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0219Add 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
36800-219-01	3680002190136800021901	1 BOTTLE in 1 CARTON (36800-219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 10, 2019
36800-219-49	3680002194936800021949	1 BOTTLE in 1 CARTON (36800-219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Apr 13, 2022

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 Mucus DM
Generic name (nonproprietary): dextromethorphan hydrobromide, guaifenesin
Active ingredients: Dextromethorphan hydrobromide — 30 mg/1Guaifenesin — 600 mg/1
Dosage form: Tablet, 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 207602
Marketing start: Jul 10, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 36800-219_a59ff297-ad60-4509-bab4-10ff482cb045SPL ID a59ff297-ad60-4509-bab4-10ff482cb045
Pharmacologic class: Expectorant; 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

N436800021901 followed by a unit qualifier and the quantity

Package 36800-0219-01. 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 36800-219

What is NDC 36800-219?: 36800-219 is the product NDC for Topcare Mucus DM, Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 tablet, 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 Mucus DM (Dextromethorphan hydrobromide, guaifenesin).
What is the active ingredient?: Dextromethorphan hydrobromide, Guaifenesin.
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 Mucus DM?: 1 other product NDC are listed under this name. See all Topcare Mucus 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 Mucus DM NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Topcare Mucus DMdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Topco Associates LLC	36800-592	36800-0592-3036800-0592-66

Other NDCs under ANDA 207602

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

FDA NDC Directory listings under ANDA 207602
Product	Strength	Form · route	Labeler	Product NDC
basic care mucus dmdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Amazon.com Services LLC	72288-812
Topcare Mucus DMdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Topco Associates LLC	36800-592
mucus dmdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Meijer Distribution Inc	41250-812
mucus dmdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	HyVee Inc	42507-812
Rugby Mucus Relief DM ERdextromethorphan hydrobromide, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7891
Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	L. Perrigo Company	0113-2219
Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Sportpharm LLC	85766-172
Robitussin Maximum Strength 12 Hour Cough and Mucus Reliefdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Haleon US Holdings LLC	0031-8765
Mucus Relief DMdextromethorphan hydrobromide, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-671
up and up mucus relief dmdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Target Corporation	11673-716
Good Neighbor Pharmacy Mucus DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Amerisource Bergen	46122-817
Berkley and Jensen Mucus Relief DMdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	BJWC	68391-812
mucus dm extended releaseguaifenesin, dextromethorphan hbr	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	CVS Pharmacy	69842-812
members mark mucus relief dmdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Sam's West Inc	68196-812
mucus relief dmdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Meijer Distribution Inc	41250-436
kirkland signature mucus dmdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1	Tablet, Extended releaseOral	Costco Wholesale Company	63981-812
equaline mucus dmdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	United Natural Foods, Inc. dba UNFI	41163-599
Mucus DM Maxdextromethorphan hbr, guaifenesin	Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1	Tablet, Extended releaseOral	Amazon.com Services LLC	72288-420
Rugby Mucus Relief DM ERdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Rugby Laboratories	0536-1446
Mucus Relief DMdextromethorphan hydrobromide, guaifenesin	Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1	Tablet, Extended releaseOral	Walgreen Company	0363-3219

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