NDC product

Diclofenac Sodium and Misoprostol

NDC 0591-0397 · Actavis Pharma, Inc.

Key facts

Product NDC 0591-0397
Proprietary name Diclofenac Sodium and Misoprostol
Nonproprietary name Diclofenac Sodium and Misoprostol
Substances DICLOFENAC SODIUM, MISOPROSTOL
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Actavis Pharma, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA201089
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC] and 2 more
Marketing start Nov 1, 2012
Listing certified through Dec 31, 2027

At a glance

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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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