MICRhoGAM Ultra-Filtered PLUS

Product NDC: 0562-7806
11-digit product format: 005627806
Labeler code: 0562
Product ID: 0562-7806_fd670401-c911-45aa-a41f-b243d30800c1
Type: PLASMA DERIVATIVE
Nonproprietary name: HUMAN RHO(D) IMMUNE GLOBULIN
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Kedrion Biopharma Inc
Application: BLA103777
Marketing category: BLA
Marketing start: 2007-03-09
Marketing end: 0000-00-00
Substance: HUMAN RHO(D) IMMUNE GLOBULIN
Active strength: 50 ug/1
Pharmacologic classes: Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag: No
Listing certified through: 2024-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0562-7806		D	Discontinued by firm	2026-08-03
excluded package	package	0562-7806	0562-7806-01	D	Discontinued by firm	2026-08-03
excluded package	package	0562-7806	0562-7806-05	D	Discontinued by firm	2026-08-03
excluded package	package	0562-7806	0562-7806-25	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 · 36 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
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	0562-7806		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0562-7806	0562-7806-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0562-7806	0562-7806-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0562-7806	0562-7806-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	0562-7806		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0562-7806	0562-7806-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0562-7806	0562-7806-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0562-7806	0562-7806-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	0562-7806		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0562-7806	0562-7806-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0562-7806	0562-7806-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0562-7806	0562-7806-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0562-7806		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0562-7806	0562-7806-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0562-7806	0562-7806-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0562-7806	0562-7806-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0562-7806		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0562-7806	0562-7806-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0562-7806	0562-7806-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0562-7806	0562-7806-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0562-7806		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0562-7806	0562-7806-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0562-7806	0562-7806-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0562-7806	0562-7806-25	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0562-7806		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0562-7806	0562-7806-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0562-7806	0562-7806-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0562-7806	0562-7806-25	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0562-7806		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0562-7806	0562-7806-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0562-7806	0562-7806-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0562-7806	0562-7806-25	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	0562-7806		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0562-7806	0562-7806-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0562-7806	0562-7806-25	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0562-7806	0562-7806-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0562-7806-01	2024-12-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2024-12-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2024-12-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2024-12-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2024-12-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2024-12-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2024-08-02	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2024-08-02	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2024-08-02	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2024-08-02	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2024-08-02	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2024-08-02	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2024-07-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2024-07-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2024-07-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2024-07-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2024-07-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2024-07-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2024-01-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2024-01-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2024-01-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2024-01-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2024-01-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2024-01-30	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2022-12-16	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2022-12-16	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2022-12-16	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2022-12-16	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2022-12-16	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2022-12-16	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2022-07-29	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-01	2022-07-29	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2022-07-29	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-05	2022-07-29	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2022-07-29	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968
0562-7806-25	2022-07-29	C162847	48780-1	e4f33bdf-ab3a-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use RhoGAM Ultra-Filtered PLUS (RhoGAM) safely and effectively. See full prescribing information for RhoGAM. RhoGAM ® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) (1500 IU), prefilled syringe, for intramuscular use Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0562-7806-00	MICRhoGAM Ultra-Filtered PLUS	1 in 1 POUCH	INJECTION, SOLUTION	1	19
0562-7806-01	MICRhoGAM Ultra-Filtered PLUS	1 in 1 CARTON	INJECTION, SOLUTION	1	19
0562-7806-05	MICRhoGAM Ultra-Filtered PLUS	5 in 1 CARTON	INJECTION, SOLUTION	5	19
0562-7806-25	MICRhoGAM Ultra-Filtered PLUS	25 in 1 CARTON	INJECTION, SOLUTION	25	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0562-7806-00	EA - Each	0562-7806	2053adf0-ccf1-426a-ab11-31264df18598	1	2014-02-04
0562-7806-01	EA - Each	0562-7806	42899d5c-8323-444c-974f-c291b4721fed	1	2012-07-24
0562-7806-05	EA - Each	0562-7806	ae316482-2490-47ee-8b02-8da135b27037	1	2012-07-24
0562-7806-25	EA - Each	0562-7806	ecb11afd-ba62-4851-9f38-7c68c2343682	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HUMAN RHO(D) IMMUNE GLOBULIN	ACTIVE INGREDIENT	48W7181FLP	RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]	8
HUMAN RHO(D) IMMUNE GLOBULIN	ACTIVE MOIETY	48W7181FLP	RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]	8
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]	8
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION MELVILLE, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0562-7806	RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION BIOPHARMA INC]	18	Legacy NDC, 4 package rows	20250101_d87e4d0b-2442-4135-b3f9-5c4f74845b87.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103777	Micrhogam, Rhogam	Rho(D) Immune Globulin (Human)	351(a)	Disc	2026-06-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
48W7181FLP	HUMAN RHO(D) IMMUNE GLOBULIN	HUMAN RHO(D) IMMUNE GLOBULIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
731380	MICRhoGAM 250 UNT (50 MCG) Prefilled Syringe	PSN	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
731381	rho(D) immune globulin, human 1500 UNT (300 MCG) Prefilled Syringe	PSN	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
1790353	rho(D) immune globulin, human 250 UNT (50 MCG) Prefilled Syringe	PSN	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
731383	RhoGAM 1500 UNT (300 MCG) Prefilled Syringe	PSN	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
731383	Rho(D) immune globulin, human 1500 UNT Prefilled Syringe [RhoGAM]	SBD	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
731380	Rho(D) immune globulin, human 250 UNT Prefilled Syringe [MICRhoGAM]	SBD	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
731381	Rho(D) immune globulin, human 1500 UNT Prefilled Syringe	SCD	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
1790353	Rho(D) immune globulin, human 250 UNT Prefilled Syringe	SCD	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
731380	MICRhoGAM 250 UNT Prefilled Syringe	SY	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19
731383	RhoGAM 1500 UNT Prefilled Syringe	SY	d87e4d0b-2442-4135-b3f9-5c4f74845b87	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0562-7806-00	00562780600	1 in 1 POUCH						Historical
0562-7806-01	00562780601	1 POUCH in 1 CARTON (0562-7806-01) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00)	1 pouch	2007-03-09	0000-00-00	No	No	Current
0562-7806-05	00562780605	5 POUCH in 1 CARTON (0562-7806-05) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00)	5 pouch	2007-03-09	0000-00-00	No	No	Current
0562-7806-25	00562780625	25 POUCH in 1 CARTON (0562-7806-25) > 1 INJECTION, SOLUTION in 1 POUCH (0562-7806-00)	25 pouch	2007-03-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RhoGAM Ultra-Filtered PLUS - Kedrion Biopharma Inc \| Kedrion Biopharma Inc.	Kedrion Biopharma Inc \| Kedrion Biopharma Inc.	2025-07-24	PLASMA DERIVATIVE	19