FDA.reportPublic FDA data

NDC 70710-1838-01 - Methylene blue

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
70710-1838
Requested NDC
70710-1838-01
Package NDCs from labels
70710-1838-1, 70710-1838-5, 70710-1838-01
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited
Effective date
2026-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methylene blue - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2026-04-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1838-1Methylene blue10 mL in 1 VIALINJECTION1010
70710-1838-5Methylene blue5 in 1 CARTONINJECTION510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1838METHYLENE BLUE INJECTION [ZYDUS PHARMACEUTICALS USA INC.]9Current NDC, 2 package rows20250309_8c56fbad-a449-4ed4-a55f-1694e4e8e26a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1838-1ML - Milliliter70710-1838f1ebd196-c489-43bd-b421-acf6283c33aa12024-01-04
70710-1838-5ML - Milliliter70710-1838c28cd653-7ea3-48b3-a3cd-f810382870ce12024-01-04

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 3 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
unii: B22547B95K
METHYLENE BLUEMETHYLENE BLUEGLENMARK PHARMACEUTICALS INC., USAeec9bc86-b15b-4c0c-a669-65b03b73da0b2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Methylene blueMETHYLENE BLUEZydus Lifesciences Limiteddf3568d6-d509-4c93-9a92-0e3d1d8514dc2026-04-02Exact identifier
application number: ANDA215636
rxcui: 1737852
rxcui: 2199323
rxcui: 1788984
unii: T42P99266K
Methylene blueMETHYLENE BLUEZydus Pharmaceuticals USA Inc.8c56fbad-a449-4ed4-a55f-1694e4e8e26a2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215636
ndc (package): 70710-1838-5
ndc (package): 70710-1837-5
ndc (package): 70710-2083-5
ndc (package): 70710-2083-1
ndc (package): 70710-1837-1
ndc (package): 70710-1838-1
ndc (product): 70710-1838
ndc (product): 70710-1837
ndc (product): 70710-2083
ndc11 (package): 70710183801
rxcui: 1737852
rxcui: 2199323
rxcui: 1788984
spl id: 9a71c3d4-778d-4566-a060-8ec69cf93871
spl set id: 8c56fbad-a449-4ed4-a55f-1694e4e8e26a
unii: T42P99266K
Methylene BlueMETHYLENE BLUEOLIC (Thailand) Limitedd115faab-577f-4299-87ed-8d4f909b46592026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Methylene BlueMETHYLENE BLUEBPI LABS LLCe2d9d96c-a711-47c5-855a-7eb7f163493e2026-03-11Boxed warning, WarningsExact identifier
rxcui: 1737852
unii: T42P99266K
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.f650dd78-615c-42d3-9b2d-3a989039d80c2026-03-05Warnings, Adverse reactionsExact identifier
unii: T42P99266K
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
Methylene blueMETHYLENE BLUEHikma Pharmaceuticals USA Inc.4f222ee5-df03-46d5-a060-c63565b7186f2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: B22547B95K
METHYLENE BLUEMETHYLENE BLUEChengdu Shuode Pharmaceutical Co., Ltdfe47491d-810e-466a-aab2-aa92756492ba2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1788984
unii: T42P99266K
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Ozipco 1% METHYLENE BLUEMETHYLENE BLUEFast Sold LLC48e789a0-6ee6-c510-e063-6294a90afba02026-01-21WarningsExact identifier
unii: T42P99266K

Reported adverse events (FAERS/openFDA)#

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