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NDC 76162-801, guaifenesin and pseudoephedrine hydrochloride, tablet, multilayer, extended release, from Topco Associates LLC.

Product NDC
76162-801
Status
Listed
Labeler
Topco Associates LLC
Dosage form
TABLET, MULTILAYER, EXTENDED RELEASE
Route
ORAL
Product type
HUMAN OTC DRUG
Marketing category
ANDA
Application
ANDA214407
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/76162-801 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • GUAIFENESIN600 mg/1
  • PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Pharmacologic classes

Adrenergic alpha-Agonists [MoA]; Decreased Respiratory Secretion Viscosity [PE]; Expectorant [EPC]; Increased Respiratory Secretions [PE]; alpha-Adrenergic Agonist [EPC]

Package NDCNDC-11Package
76162-801-89761620801891 BLISTER PACK in 1 CARTON (76162-801-89) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

Linked data

RxNorm, label and prices

RxNorm concepts

RxNorm links no concept to this product's packages.

Related lookups

No FDA label, Medicare Part B payment limit or NADAC price is linked to this product.

Use it

Look up 76162-801 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/76162-801 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 76162-801. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.
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Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.