NDC11 00378661185

This exact 11-digit normalized identifier can correspond to more than one FDA hyphenation. FDA.report preserves the exact identifier and exposes every structurally valid candidate without guessing.

Possible FDA NDC forms#

Package NDC, Product root table
Package NDC	Product root
00378-6611-85	00378-6611
0378-6611-85	0378-6611

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amnesteem	ISOTRETINOIN	Mylan Pharmaceuticals Inc.	b2cb63c9-f825-4991-9a2c-6260f1bbcc2c	2026-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 0378-6611-85 ndc (product): 0378-6611 ndc11 (package): 00378661185

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.