BabyBIG 100 MG Injection

RxCUI: 544495
RxNorm name: BabyBIG 100 MG Injection
Display name: BabyBIG 100 MG Injection
Full name: BabyBIG 100 MG Injection
Term type: SY
Status: DailyMed mapping
Updated: 2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125034	BabyBig	Botulism Immune Globulin Intravenous (Human)	351(a)	Rx	2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BabyBIG	HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN	CALIFORNIA DEPARTMENT OF PUBLIC HEALTH	9ec59262-35c1-4d8e-8451-a7cfbacb0675	2025-12-08	Warnings, Adverse reactions	Exact identifier rxcui: 544495

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
9ec59262-35c1-4d8e-8451-a7cfbacb0675	BabyBIG 100 MG Injection	SY	14	These highlights do not include all the information needed to use BabyBIG, [Botulism Immune Globulin Intravenous (Human)], safely and effectively. See full prescribing information for BabyBIG. BabyBIG [Botulism Immune Globulin Intravenous (Human) (BIG-IV)] Lyophilized Powder for Reconstitution and Injection Initial U.S. Approval: 2003	20251208
9ec59262-35c1-4d8e-8451-a7cfbacb0675	BabyBIG 100 MG Injection	PSN	14	These highlights do not include all the information needed to use BabyBIG, [Botulism Immune Globulin Intravenous (Human)], safely and effectively. See full prescribing information for BabyBIG. BabyBIG [Botulism Immune Globulin Intravenous (Human) (BIG-IV)] Lyophilized Powder for Reconstitution and Injection Initial U.S. Approval: 2003	20251208
9ec59262-35c1-4d8e-8451-a7cfbacb0675	botulism immune globulin IV human 100 MG Injection [BabyBIG]	SBD	14	These highlights do not include all the information needed to use BabyBIG, [Botulism Immune Globulin Intravenous (Human)], safely and effectively. See full prescribing information for BabyBIG. BabyBIG [Botulism Immune Globulin Intravenous (Human) (BIG-IV)] Lyophilized Powder for Reconstitution and Injection Initial U.S. Approval: 2003	20251208