FDA.reportPublic FDA data

METHYLENE BLUE

Product NDC
70700-328
11-digit product format
707000328
Labeler code
70700
Product ID
70700-328_3eddefa4-0024-493a-e063-6294a90a1b49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLENE BLUE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
XIROMED, LLC
Application
ANDA219363
Marketing category
ANDA
Marketing start
2025-09-28
Substance
METHYLENE BLUE
Active strength
50 mg/10mL
Pharmacologic classes
Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219363-001METHYLENE BLUEMETHYLENE BLUE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP2025-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219363-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219363-001METHYLENE BLUE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP2025-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219363-001METHYLENE BLUE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP2025-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A219363-001METHYLENE BLUE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP2025-07-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219363-001METHYLENE BLUE50MG/10ML (5MG/ML)SOLUTION / INTRAVENOUSAP2025-07-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219363-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219363-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219363-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219363-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
METHYLENE BLUE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLENE BLUE50 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T42P99266KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1788984Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
691a6872-bc2f-d492-11c6-c3eec25aa3d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-328-22METHYLENE BLUE10 mL in 1 VIAL, SINGLE-DOSEINJECTION101
70700-328-24METHYLENE BLUE5 in 1 CARTONINJECTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-328-22ML - Milliliter70700-328922f84ea-0ea7-4131-8ca6-e1af05a542b712025-11-13
70700-328-24ML - Milliliter70700-328fde7c165-a98e-4649-89ac-551ded3f900912025-11-13

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLENE BLUEMETHYLENE BLUEXIROMED, LLC691a6872-bc2f-d492-11c6-c3eec25aa3d32026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219363
application number: ANDA219363
ndc (product): 70700-328

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1788984methylene blue 50 MG in 10 ML InjectionPSN691a6872-bc2f-d492-11c6-c3eec25aa3d31
178898410 ML methylene blue 5 MG/ML InjectionSCD691a6872-bc2f-d492-11c6-c3eec25aa3d31
1788984methylene blue 50 MG per 10 ML InjectionSY691a6872-bc2f-d492-11c6-c3eec25aa3d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70700-328-227070003282210 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
70700-328-24707000328245 VIAL, SINGLE-DOSE in 1 CARTON (70700-328-24) / 10 mL in 1 VIAL, SINGLE-DOSE (70700-328-22) 2025-09-28NoNoCurrent