NDC product

Isotretinoin

NDC 0245-0575 · Upsher-Smith Laboratories, LLC

Key facts

Product NDC 0245-0575
Proprietary name Isotretinoin
Nonproprietary name Isotretinoin
Substances ISOTRETINOIN
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA213571
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
Marketing start Apr 12, 2021
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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