FDA.reportPublic FDA data

NDC 13533-636-50 - HYPERHEP B

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
13533-636
Requested NDC
13533-636-50
Package NDCs from labels
13533-636-10, 13533-636-01, 13533-636-20, 13533-636-02, 13533-636-30, 13533-636-03, 13533-636-50, 13533-636-05
Manufacturer
GRIFOLS USA, LLC | Grifols Therapeutics LLC
Effective date
2024-09-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYPERHEP B - GRIFOLS USA, LLC | Grifols Therapeutics LLCGRIFOLS USA, LLC | Grifols Therapeutics LLC2024-09-20PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-636-01HYPERHEP B1 in 1 CARTONINJECTION126
13533-636-02HYPERHEP B1 in 1 CARTONINJECTION126
13533-636-03HYPERHEP B1 in 1 CARTONINJECTION126
13533-636-05HYPERHEP B1 in 1 CARTONINJECTION126
13533-636-10HYPERHEP B1 mL in 1 VIAL, GLASSINJECTION126
13533-636-20HYPERHEP B1 mL in 1 SYRINGE, GLASSINJECTION126
13533-636-30HYPERHEP B0.5 mL in 1 SYRINGE, GLASSINJECTION0.526
13533-636-50HYPERHEP B5 mL in 1 VIAL, GLASSINJECTION526

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-636HYPERHEP B (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]26Current NDC, Legacy NDC, 8 package rows20241004_cda35690-672f-46cd-8520-e37f4d66a8d7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13533-636-01ML - Milliliter13533-6360f0cf9b8-7a6a-4d52-bcca-74b071a1a8ef12013-02-13
13533-636-02ML - Milliliter13533-63685a8f3c8-6673-47c2-af7c-92a763a23b6712012-07-24
13533-636-03ML - Milliliter13533-636244c9c74-7758-42a8-8420-490cdf24362f12012-07-24
13533-636-05ML - Milliliter13533-63620ea87c0-3b0b-4270-b11c-f23a360d03ac12012-07-24
13533-636-10ML - Milliliter13533-6360367b921-2e73-4232-a69a-189af775391712015-10-02
13533-636-20ML - Milliliter13533-63675dbb46e-137c-4fa8-8a27-a64f10f1b92112014-10-03
13533-636-30ML - Milliliter13533-636fe7bca80-ae82-4cbf-8469-edc83424699812014-10-03
13533-636-50ML - Milliliter13533-6367447a359-789f-435c-a393-daf51915352412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Human Hepatitis B Virus Immune GlobulinACTIVE INGREDIENTXII270YC6MHYPERHEP B S/D (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]12
Human Hepatitis B Virus Immune GlobulinACTIVE MOIETYXII270YC6MHYPERHEP B S/D (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]12
GlycineINACTIVE INGREDIENTTE7660XO1CHYPERHEP B S/D (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 10 · 182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.