NDC product

Ibuprofen

NDC 35916-0989 · Softgel Healthcare Private Limited

Key facts

Product NDC 35916-0989
Proprietary name Ibuprofen
Nonproprietary name Ibuprofen
Substances IBUPROFEN
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Private Limited
Product type HUMAN OTC DRUG
Marketing category OTC MONOGRAPH DRUG
Application number 505G(a)(3)
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing start Jan 10, 2025
Listing certified through Dec 31, 2027

At a glance

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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