NDC product

Sertraline Hydrochloride

NDC 69097-438 · Cipla USA Inc.

Key facts

Product NDC 69097-438
Proprietary name Sertraline Hydrochloride
Nonproprietary name Sertraline Hydrochloride
Substances SERTRALINE HYDROCHLORIDE
Dosage form CAPSULE
Route ORAL
Labeler Cipla USA Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA218853
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
Marketing start Jul 17, 2025
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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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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