FDA.reportPublic FDA data

BabyBIG

Product NDC
68403-1100
11-digit product format
684031100
Labeler code
68403
Product ID
68403-1100_1081f6db-619b-4e42-946c-d278789a588a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
human botulinum neurotoxin a/b immune globulin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
Application
BLA125034
Marketing category
BLA
Marketing start
2003-10-23
Substance
HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN
Active strength
50 mg/mL
Pharmacologic classes
Antitoxins [CS], Bacterial Neurotoxin Neutralization [MoA], Human Immunoglobulin G [EPC], Passively Acquired Immunity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BabyBIG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX641Y30OA7
Rxcui544491, 544495

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68403-1100-62021-07-08C16284748780-1ba0f9c33-5c9a-a910-e053-dadaa90a0b85These 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
68403-1100-62021-01-29C16284748780-1ba0f9c33-5c9a-a910-e053-dadaa90a0b85These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68403-1100-6BabyBIG2 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,214
68403-1100-7BabyBIG1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68403-1100-6EA - Each68403-1100e0a9a9dd-b87d-44e2-a8c1-e9469da3d7bc12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
human botulinum neurotoxin a/b immune globulinACTIVE INGREDIENTX641Y30OA7BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH]9
human botulinum neurotoxin a/b immune globulinACTIVE MOIETYX641Y30OA7BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH]9
albumin humanINACTIVE INGREDIENTZIF514RVZRBABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH]9
sodium phosphate, monobasic, anhydrousINACTIVE INGREDIENTKH7I04HPUUBABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH]9
sucroseINACTIVE INGREDIENTC151H8M554BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68403-1100BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH]13Current NDC, Legacy NDC, 2 package rows20241208_9ec59262-35c1-4d8e-8451-a7cfbacb0675.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
544495BabyBIG 100 MG InjectionPSN9ec59262-35c1-4d8e-8451-a7cfbacb067514
544491botulism immune globulin, human 100 MG InjectionPSN9ec59262-35c1-4d8e-8451-a7cfbacb067514
544495botulism immune globulin IV human 100 MG Injection [BabyBIG]SBD9ec59262-35c1-4d8e-8451-a7cfbacb067514
544491botulism immune globulin IV human 100 MG InjectionSCD9ec59262-35c1-4d8e-8451-a7cfbacb067514
544495BabyBIG 100 MG InjectionSY9ec59262-35c1-4d8e-8451-a7cfbacb067514
544491botulism immune globulin, human 100 MG InjectionSY9ec59262-35c1-4d8e-8451-a7cfbacb067514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68403-1100-6684031100062 mL in 1 VIAL, SINGLE-USE2 mlHistorical
68403-1100-7684031100071 VIAL, SINGLE-USE in 1 CARTON (68403-1100-7) / 2 mL in 1 VIAL, SINGLE-USE (68403-1100-6) 2003-10-230000-00-00NoNoCurrent