FDA.reportPublic FDA data

NDC 0085-4346-01 - INTRON A

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
0085-4346
Requested NDC
0085-4346-01
Package NDCs from labels
0085-4346-01
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2023-03-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
INTRON A - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2023-03-07HUMAN PRESCRIPTION DRUG LABEL
PEGINTRON - Merck Sharp & Dohme Corp.Merck Sharp & Dohme Corp.2020-11-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Peginterferon alfa-2bACTIVE INGREDIENTG8RGG88B68PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]5
interferon alfa-2bACTIVE MOIETY43K1W2T1M6PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]5
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]5
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6FPEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]5
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK665956PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]5
sucroseINACTIVE INGREDIENTC151H8M554PEGINTRON (PEGINTERFERON ALFA-2B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PEGINTRON (PEGINTERFERON ALFA-2B) KIT [MERCK SHARP & DOHME CORP.]5
interferon alfa-2bACTIVE INGREDIENT43K1W2T1M6INTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
Interferon alfa-2bACTIVE MOIETY43K1W2T1M6INTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
Albumin (Human)INACTIVE INGREDIENTZIF514RVZRINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
edetate disodiumINACTIVE INGREDIENT7FLD91C86KINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
GlycineINACTIVE INGREDIENTTE7660XO1CINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
metacresolINACTIVE INGREDIENTGGO4Y809LOINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74INTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWINTRON A (INTERFERON ALFA-2B) KIT INTRON A (INTERFERON ALFA-2B) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.]3

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 29 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-53AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, AND BOS TAURUS PLACENTADNA Labs, Inc.3787d569-ee4d-41de-9519-73c11b626b382025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-51ATROPA BELLADONNA, IODINE, LYCOPUS VIRGINICUS, SODIUM CHLORIDE, HEKLA LAVA, AND CALCIUM HEXAFLUOROSILICATEDNA Labs, Inc.9928dd54-bd3a-47cb-bde5-4bebab3db6832025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: 451W47IQ8X
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
A-5SUCROSEDNA Labs, Inc.8e63f697-26c1-4518-acd3-5ea72cfa27f72025-01-09WarningsExact identifier
unii: C151H8M554
A-36BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAFDNA Labs, Inc.161c4738-9ead-4687-9f5a-029d5a496e072025-01-09WarningsExact identifier
unii: 451W47IQ8X
AM-11ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERADNA Labs, Inc.c072811b-6259-4b22-b364-50369dc68fb02025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-13CEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, AND SUS SCROFA SPLEENDNA Labs, Inc.146c5465-bcd9-4057-8975-dc1088b9971b2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-10SODIUM CHLORIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, IODINE, LYCOPODIUM CLAVATUM WHOLE, AND BOS TAURUS PITUITARY GLAND, POSTERIORDNA Labs, Inc.264d8093-70f3-43a5-bfc4-b719bb3e45e62025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 451W47IQ8X
unii: TE7660XO1C
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-14FUCUS VESICULOSUS, SODIUM CHLORIDE, LYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, POTASSIUM IODIDE, CALCIUM IODIDE, THYROID, UNSPECIFIED, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS THYMUS, AND SUS SCROFA SPLEENDNA Labs, Inc.3d64739c-5d61-4e88-8612-d5f6994f1c3c2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 451W47IQ8X
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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