NDC 0053-7653 - Zemaira

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: 0053-7653
Package NDCs from labels: 0053-7653-20, 0053-7653-80, 0053-7653-12, 0053-7653-52, 0053-7653-07
Manufacturer: CSL Behring LLC
Effective date: 2024-09-23
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Zemaira - CSL Behring LLC	CSL Behring LLC	2024-09-23	PLASMA DERIVATIVE
Helixate FS - CSL Behring LLC \| Bayer HealthCare LLC	CSL Behring LLC \| Bayer HealthCare LLC	2016-05-31	PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0053-7653	ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT ZEMAIRA (.ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]	27	Unmatched	20240926_0c3354b5-a1d8-4f98-ad55-2eafe4265c4e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
alpha-1-proteinase inhibitor human	ACTIVE INGREDIENT	F43I396OIS	ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]	16
alpha-1-proteinase inhibitor human	ACTIVE MOIETY	F43I396OIS	ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]	16
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]	16
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]	16
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]	16
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]	16
Sodium Phosphate	INACTIVE INGREDIENT	SE337SVY37	ZEMAIRA (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [CSL BEHRING LLC]	16
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	ACTIVE INGREDIENT	P89DR4NY54	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT	ACTIVE MOIETY	P89DR4NY54	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
CALCIUM	INACTIVE INGREDIENT	SY7Q814VUP	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
CHLORIDE ION	INACTIVE INGREDIENT	Q32ZN48698	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
COPPER	INACTIVE INGREDIENT	789U1901C5	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
SODIUM POLYMETAPHOSPHATE	INACTIVE INGREDIENT	P1BM4ZH95L	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14
TRI-N-BUTYL PHOSPHATE	INACTIVE INGREDIENT	95UAS8YAF5	HELIXATE FS (ANTIHEMOPHILIC FACTOR, RECOMBINANT) KIT [CSL BEHRING LLC]	14

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 25 of 66 · 1,311 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose and Sodium Chloride	DEXTROSE AND SODIUM CHLORIDE	Baxter Healthcare Company	dcbf1907-1841-4afc-ab5d-a9893a2d7256	2025-08-26	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
terrasil Fast and Natural Wart Removal	GRAPHITE 10X, NATRUM MURIATICUM 3X, SYMPHYTUM OFFICINALE (COMFREY) 1X, THUJA OCCIDENTALIS 3X	Aidance Scientific, Inc.	3d367c0f-5a28-eded-e063-6394a90ad2dc	2025-08-25	Warnings	Exact identifier unii: 451W47IQ8X
Cold Sore Treatment Extra Strength	ECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, AND CALENDULA OFFICINALIS FLOWERING TOP	Forces of Nature	0a5d32dc-c0e7-404e-85f2-6c3a338560ba	2025-08-22	Warnings	Exact identifier unii: 451W47IQ8X
Incontinence	ALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTIS	Newton Laboratories, Inc.	994cbc8e-a221-1548-e053-2995a90a1f7f	2025-08-20	Warnings	Exact identifier unii: 451W47IQ8X
Fungus Fighter	CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.	Newton Laboratories, Inc.	93e05175-001b-c639-e053-2a95a90a289c	2025-08-19	Warnings	Exact identifier unii: 789U1901C5
Fungus Fighter	CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.	Newton Laboratories, Inc.	9b4276af-b738-3293-e053-2a95a90ad022	2025-08-19	Warnings	Exact identifier unii: 789U1901C5
Jacksons Cell Salts NAT MUR 6X 9	NATRUM MURIATICUM	Zettl Health Inc.	3cbe47fc-db38-e6e9-e063-6294a90a3f1c	2025-08-19	Warnings	Exact identifier unii: 451W47IQ8X
QUALITY CHOICE SALINE	SODIUM CHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	f51491d8-12ad-4b1b-a171-c621bfdcc341	2025-08-12	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Henry Schein, Inc.	e0466bb3-6c26-4044-b051-69f48b67f632	2025-08-07	Adverse reactions	Exact identifier unii: 451W47IQ8X
Schuessler Tissue Salts Nat Mur Fluid Balance 9	NATRUM MURIATICUM	Martin & Pleasance Pty Ltd	08da6353-9625-4e8f-8575-a2b49f5d2ac6	2025-08-04	Warnings	Exact identifier unii: 451W47IQ8X
Gout Relief 3310-S	CELERY SEED, MEDICAGO SATIVA WHOLE,CHICORY ROOT	Bispit Canada Ltd.	3afaa7d9-3de3-52d9-e063-6294a90a54ec	2025-08-02	Warnings	Exact identifier unii: 451W47IQ8X
Renes Cuprum	RENES CUPRUM	Uriel Pharmacy Inc.	0f3de3bf-a6af-4328-e063-6394a90a57ab	2025-08-01	Warnings	Exact identifier unii: 789U1901C5
QUALITY CHOICE SALINE	PLUS SOOTHING ALOE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	4ae4e88a-aaa5-4195-bedc-622fd5cd9394	2025-07-30	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	9e72418a-376e-4637-99ad-d13c904a7986	2025-07-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Cell Salts	CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA	Newton Laboratories, Inc.	985a3341-0fe0-1dd6-e053-2a95a90ad2c5	2025-07-25	Warnings	Exact identifier unii: 451W47IQ8X
Dairy-Grain-Nightshade	IRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.	Newton Laboratories, Inc.	99fcbd61-ecc8-cf9d-e053-2995a90aebeb	2025-07-25	Warnings	Exact identifier unii: 451W47IQ8X
Bedwetting	ECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUS	Newton Laboratories, Inc.	9d5f51d0-01e9-271c-e053-2995a90a63bc	2025-07-24	Warnings	Exact identifier unii: 451W47IQ8X
Bedwetting	ECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUS	Newton Laboratories, Inc.	9d6058a0-69dd-66d0-e053-2a95a90a58f8	2025-07-24	Warnings	Exact identifier unii: 451W47IQ8X
Cell Salts	CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA	Newton Laboratories, Inc.	7a1b4e96-c96f-6424-e053-2991aa0aef30	2025-07-24	Warnings	Exact identifier unii: 451W47IQ8X
Cell Salts	CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA	Newton Laboratories, Inc.	7a1a9ef9-9a54-5f94-e053-2a91aa0ab477	2025-07-24	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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