What is NDC 54288-159?

54288-159 is the product NDC for Methylene Blue, Methylene blue 10 mg/mL injection, listed with the FDA by BPI LABS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

BPI LABS LLC, NDC labeler code 54288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Methylene Blue?

18 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methylene Blue NDC 54288-159 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54288-159Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54288-0159Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
54288-159-05	5428801590554288015905	5 SYRINGE in 1 PACKAGE (54288-159-05) / 2 mL in 1 SYRINGE (54288-159-01)Marketed from May 15, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Methylene Blue
Generic name (nonproprietary): methylene blue
Active ingredients: Methylene blue — 10 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: BPI LABS LLCNDC labeler code 54288
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: May 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Oxidation-Reduction Activity (Mechanism)
Identifiers: Product ID 54288-159_e36054e3-076c-46d7-82f1-33b3d9481376SPL ID e36054e3-076c-46d7-82f1-33b3d9481376SPL set ID fbdd583d-45ba-4d42-8c80-9a13b71980b6RxCUI 2637038UNII T42P99266KUPC 0354288159050, 0354288159012
Pharmacologic class: Oxidation-Reduction Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N454288015905 followed by a unit qualifier and the quantity

Package 54288-0159-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 26, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE : Drug-induced methemoglobinemia

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54288-159

What is NDC 54288-159?: 54288-159 is the product NDC for Methylene Blue, Methylene blue 10 mg/mL injection, listed with the FDA by BPI LABS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methylene Blue.
What is the active ingredient?: Methylene blue.
Who is the labeler?: BPI LABS LLC, NDC labeler code 54288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methylene Blue?: 18 other product NDCs are listed under this name. See all Methylene Blue NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methylene Blue NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methylene blue	Methylene blue 10 mg/mL	InjectionIntravenous	Zydus Pharmaceuticals USA Inc.	70710-2083	70710-2083-0170710-2083-05
Methylene blue	Methylene blue 10 mg/mL	InjectionIntravenous	Zydus Lifesciences Limited	70771-1963	70771-1963-0170771-1963-05
Methylene blue	Methylene blue 50 mg/10mL	Injection, SolutionIntravenous	Steriscience Specialties Private Limited	82449-003	82449-0003-06
Methylene Blue	Methylene blue 50 mg/10mL	InjectionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-698	68462-0698-15
Methylene Blue	Methylene blue 50 mg/10mL	InjectionIntravenous	Chengdu Shuode Pharmaceutical Co., Ltd	82432-104	82432-0104-02
Methylene Blue	Methylene blue 50 mg/10mL	InjectionIntravenous	XIROMED, LLC	70700-328	70700-0328-24
Methylene blue	Methylene blue 5 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9094	00143-9094-05
Methylene blue	Methylene blue 5 mg/mL	Injection, SolutionIntravenous	Amneal Pharmaceuticals LLC	70121-2715	70121-2715-02
Methylene blue	Methylene blue 5 mg/mL	Injection, SolutionIntravenous	Amneal Pharmaceuticals LLC	70121-2716	70121-2716-02
Methylene blue	Methylene blue 50 mg/10mL	Injection, SolutionIntravenous	Steriscience Specialties Private Limited	82449-002	82449-0002-06

All 19 Methylene Blue NDCs