FDA.reportPublic FDA data

NDC 0085-4346 - 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
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 32 of 57 · 1,130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYc1d0f42e-3494-4217-8f86-e9f34d930e822025-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Foster and Thrive Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMcKessone5fdfcfd-5340-4929-9f68-2696110cca8e2025-01-07WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
Shingles RemedyCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLASilver Star Brands5d65c997-f5dc-4dee-e053-2a91aa0ac3192025-01-01WarningsExact identifier
unii: 451W47IQ8X
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: GR686LBA74
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 451W47IQ8X
Sweat-LessARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MURSilver Star Brands4053d10b-4b06-291b-e054-00144ff88e882025-01-01WarningsExact identifier
unii: 451W47IQ8X
NativeRemedies Triple Complex Brain TonicCALC PHOS, KALI PHOS, NAT MUR.Silver Star Brandsf76eaf46-4a80-31a9-e053-6394a90a542d2025-01-01WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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