HepaGam B

Product NDC: 70504-0054
Requested package NDC: 70504-0054-2
11-digit product format: 705040054
Labeler code: 70504
Product ID: 70504-0054_b3195063-4432-4936-9597-43eed79f87cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hepatitis B Immune Globulin (Human)
Dosage form: SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Aptevo BioTherapeutics LLC
Application: BLA125035
Marketing category: BLA
Marketing start: 2016-07-01
Marketing end: 0000-00-00
Substance: HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
Active strength: 312 [iU]/mL
Pharmacologic classes: Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [EXT],Immunoglobulins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 11 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70504-0054	70504-0054-2	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70504-0054	70504-0054-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70504-0054	70504-0054-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70504-0054	70504-0054-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70504-0054-2	2023-02-01	C162847	48780-1	d6a99b39-3698-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use HepaGam B ® safely and effectively. See full prescribing information for HepaGam B ® . HepaGam B ® [Hepatitis B Immune Globulin Intravenous (Human)], Sterile Solution for Intravenous or Intramuscular Injection Solvent/Detergent Treated and Filtered. >312 IU per milliliter (Measured potency stamped on the vial label) Initial U.S. Approval: 2006
70504-0054-2	2022-01-28	C162847	48780-1	d6a99b39-3698-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use HepaGam B ® safely and effectively. See full prescribing information for HepaGam B ® . HepaGam B ® [Hepatitis B Immune Globulin Intravenous (Human)], Sterile Solution for Intravenous or Intramuscular Injection Solvent/Detergent Treated and Filtered. >312 IU per milliliter (Measured potency stamped on the vial label) Initial U.S. Approval: 2006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70504-0054-1	ML - Milliliter	70504-0054	908e18df-7ced-4f28-ab6d-746092a326fa	1	2018-07-03
70504-0054-2	ML - Milliliter	70504-0054	043b4469-c251-4afa-be39-9d2d79fb2047	1	2018-07-03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125035	Hepagam B	Hepatitis B Immune Globulin (Human)	351(a)	Rx	2026-06-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
XII270YC6M	HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN	HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70504-0054-2	70504005402	1 VIAL in 1 CARTON (70504-0054-2) > 5 mL in 1 VIAL (70504-0054-1)	1 vial	2018-07-02	0000-00-00	No	No	Current