Application 125360

Type: BLA
Sponsor: MERZ PHARMS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125360	Xeomin	incobotulinumtoxinA	351(a)	Rx	2026-06-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	Xeomin	incobotulinumtoxinA	INJECTABLE; INJECTION	50 UNITS/VIAL	No	No
002	Xeomin	incobotulinumtoxinA	INJECTABLE; INJECTION	100 UNITS/VIAL	No	No
003	Xeomin	incobotulinumtoxinA	INJECTABLE;INJECTION	200 UNITS/VIAL	No	No

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Xeomin	INCOBOTULINUMTOXINA	Merz Pharmaceuticals, LLC	ccdc3aae-6e2d-4cd0-a51c-8375bfee9458	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125360 ndc (product): 0259-4150 ndc (product): 0259-1610 ndc (product): 0259-4110 ndc (product): 0259-1620 ndc (product): 0259-1605
Xeomin	INCOBOTULINUMTOXINA	Merz North America, Inc.	3f35d6e0-3450-4abc-a0da-cc7b277e7c6e	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125360 ndc (product): 46783-161 ndc (product): 46783-165 ndc (product): 46783-160

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 67 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1605	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1610	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-1620	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4110	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
0259-4150	Xeomin	incobotulinumtoxinA	Merz Pharmaceuticals, LLC	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-160	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-161	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current
46783-165	Xeomin	incobotulinumtoxinA	Merz North America, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85524	SUPPL	2026-03-25
85523	SUPPL	2026-03-25
85183	SUPPL	2026-03-02
85182	SUPPL	2026-03-02
84472	SUPPL	2025-12-19
84471	SUPPL	2025-12-19
75447	SUPPL	2023-09-13
75386	SUPPL	2023-09-11
68394	SUPPL	2021-08-17
68393	SUPPL	2021-08-17
68374	SUPPL	2021-08-16
67130	SUPPL	2021-04-22
67129	SUPPL	2021-04-22
67128	SUPPL	2021-04-22
67127	SUPPL	2021-04-22
67126	SUPPL	2021-04-22
67123	SUPPL	2021-04-20
67122	SUPPL	2021-04-20
67121	SUPPL	2021-04-20
67120	SUPPL	2021-04-20
67119	SUPPL	2021-04-20
65674	SUPPL	2020-12-22
65673	SUPPL	2020-12-22
65632	SUPPL	2020-12-21
65631	SUPPL	2020-12-21
65630	SUPPL	2020-12-21
65629	SUPPL	2020-12-21
64305	SUPPL	2020-08-19
64304	SUPPL	2020-08-19
64300	SUPPL	2020-08-19
58702	SUPPL	2019-05-14
58701	SUPPL	2019-05-14
58674	SUPPL	2019-05-14
54782	SUPPL	2018-07-06
54742	SUPPL	2018-07-03
31941	SUPPL	2015-12-29
39938	SUPPL	2015-12-28
18887	SUPPL	2015-11-25
18886	SUPPL	2013-04-16
9722	SUPPL	2013-04-16
9721	SUPPL	2012-07-18
18885	SUPPL	2011-07-25
24364	ORIG	2011-02-17
22804	ORIG	2010-09-29
31940	SUPPL	2010-08-06
18884	SUPPL	2010-08-06
18883	ORIG	2010-08-06
9720	ORIG	2010-08-06