What is NDC 76162-801?

76162-801 is the product NDC for topcare mucus d, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, multilayer, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

topcare mucus d (Guaifenesin and pseudoephedrine hydrochloride).

What is the active ingredient?

Guaifenesin, Pseudoephedrine hydrochloride.

Topco Associates LLC, NDC labeler code 76162. 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 d?

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.

topcare mucus d NDC 76162-801 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76162-801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76162-0801Add 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
76162-801-89	7616208018976162080189	1 BLISTER PACK in 1 CARTON (76162-801-89) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 16, 2023

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 d
Generic name (nonproprietary): guaifenesin and pseudoephedrine hydrochloride
Active ingredients: Guaifenesin — 600 mg/1Pseudoephedrine hydrochloride — 60 mg/1
Dosage form: Tablet, Multilayer, Extended release
Route: Oral
Labeler: Topco Associates LLCNDC labeler code 76162
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214407
Marketing start: Aug 16, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers: Product ID 76162-801_1a640e24-6d3d-4c6b-b06b-6dbc311974e2SPL ID 1a640e24-6d3d-4c6b-b06b-6dbc311974e2
Pharmacologic class: Expectorant; alpha-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

N476162080189 followed by a unit qualifier and the quantity

Package 76162-0801-89. 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 76162-801

What is NDC 76162-801?: 76162-801 is the product NDC for topcare mucus d, Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1 tablet, multilayer, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: topcare mucus d (Guaifenesin and pseudoephedrine hydrochloride).
What is the active ingredient?: Guaifenesin, Pseudoephedrine hydrochloride.
Who is the labeler?: Topco Associates LLC, NDC labeler code 76162. 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 d?: 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 214407

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

FDA NDC Directory listings under ANDA 214407
Product	Strength	Form · route	Labeler	Product NDC
equate mucus dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	WALMART INC.	79903-125
Equate Mucus Dguaifenesin, pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	WALMART INC.	79903-388
foster and thrive mucus relief dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	Strategic Sourcing Services LLC	70677-1272
foster and thrive mucus relief dguaifenesin, pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	Strategic Sourcing Services LLC	70677-1273
Leader Mucus Relief Dguaifenesin, pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	Cardinal Health 110, LLC. dba Leader	70000-0719
Leader Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	Cardinal Health 110, LLC. dba Leader	70000-0720
mucus Dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	L. Perrigo Company	0113-8307
Mucus Dguaifenesin, pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	L. Perrigo Company	0113-8911
mucus dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	Kroger Company	30142-739
mucus dguaifenesin, pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-345
Mucus Dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-878
mucus Dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	Meijer, Inc.	79481-0119
Mucus Dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	Meijer, Inc.	79481-0709
mucus relief dguaifenesin, pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	Walgreen Company	0363-2389
Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	Walgreen Company	0363-8708
mucus relief dguaifenesin, pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	H E B	59640-300
mucus relief dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	H E B	59640-621
nasal and chest decongestantguaifenesin, pseudoephedrine hydrochloride	Guaifenesin 1200 mg/1; Pseudoephedrine hydrochloride 120 mg/1	Tablet, Multilayer, Extended releaseOral	Publix Super Markets Inc	56062-614
Rugby Mucus Relief Dguaifenesin and pseudoephedrine hydrochloride	Guaifenesin 600 mg/1; Pseudoephedrine hydrochloride 60 mg/1	Tablet, Multilayer, Extended releaseOral	Rugby Laboratories	0536-1449