Methylene Blue

Product NDC: 54288-147
11-digit product format: 542880147
Labeler code: 54288
Product ID: 54288-147_b94f7574-e7a9-4c69-b915-6e88f226021d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylene Blue
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: BPI LABS LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2021-12-23
Substance: METHYLENE BLUE
Active strength: 10 mg/mL
Pharmacologic classes: Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Methylene Blue
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLENE BLUE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T42P99266K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1737852	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e2d9d96c-a711-47c5-855a-7eb7f163493e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c39b72c3-7732-4ed2-a995-e6aa3a665a54	Product name	3	20250819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54288-147-01	Methylene Blue	10 mL in 1 VIAL	INJECTION	10		8
54288-147-01	Methylene Blue	1 in 1 CARTON	INJECTION	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54288-147-01	ML - Milliliter	54288-147	4c0f9189-2f77-486c-b350-000f26545541	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54288-147	METHYLENE BLUE INJECTION [BPI LABS LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250213_e2d9d96c-a711-47c5-855a-7eb7f163493e.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylene Blue	METHYLENE BLUE	BPI LABS LLC	e2d9d96c-a711-47c5-855a-7eb7f163493e	2026-03-11	Boxed warning, Warnings	Exact identifier ndc (product): 54288-147

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T42P99266K	METHYLENE BLUE	7220-79-3	METHYLENE BLUE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1737852	methylene blue 100 MG in 10 ML (1 % ) Injection	PSN	e2d9d96c-a711-47c5-855a-7eb7f163493e	8
1737852	10 ML methylene blue 10 MG/ML Injection	SCD	e2d9d96c-a711-47c5-855a-7eb7f163493e	8
1737852	methylene blue 100 MG per 10 ML (1 % ) Injection	SY	e2d9d96c-a711-47c5-855a-7eb7f163493e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54288-147-01	54288014701	1 VIAL in 1 CARTON (54288-147-01) / 10 mL in 1 VIAL	1 vial	2021-12-23	0000-00-00	No	No	Current