What is NDC 0185-0128?

0185-0128 is the product NDC for Bumetanide, Bumetanide .5 mg/1 tablet, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0185. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bumetanide?

122 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bumetanide NDC 0185-0128 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0185-0128Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00185-0128Add 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
0185-0128-01	0018501280100185012801	100 TABLET in 1 BOTTLE (0185-0128-01)Marketed from Nov 21, 1996
0185-0128-05	0018501280500185012805	500 TABLET in 1 BOTTLE (0185-0128-05)Marketed from Nov 21, 1996

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Bumetanide
Generic name (nonproprietary): bumetanide
Active ingredients: Bumetanide — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sandoz IncNDC labeler code 0185
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074700
Marketing start: Nov 21, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Increased Diuresis at Loop of Henle (Physiologic effect)
Identifiers: Product ID 0185-0128_c6f31ac9-10d1-4d92-882e-836de10e1ce6SPL ID c6f31ac9-10d1-4d92-882e-836de10e1ce6SPL set ID 05cb961d-ac33-4bcf-b04e-411e496c43c1RxCUI 197417, 197418, 197419UNII 0Y2S3XUQ5HUPC 0301850128013, 0301850129010, 0301850130016
Pharmacologic class: Loop Diuretic

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400185012801 followed by a unit qualifier and the quantity

Package 00185-0128-01. 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 Jun 30, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Bumetanide tablets, USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets, USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0185-0128

What is NDC 0185-0128?: 0185-0128 is the product NDC for Bumetanide, Bumetanide .5 mg/1 tablet, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bumetanide.
What is the active ingredient?: Bumetanide.
Who is the labeler?: Sandoz Inc, NDC labeler code 0185. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bumetanide?: 122 other product NDCs are listed under this name. See all Bumetanide 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 Bumetanide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bumetanide	Bumetanide .5 mg/1	TabletOral	Sandoz Inc	0781-8099	00781-8099-0100781-8099-05
Bumetanide	Bumetanide 1 mg/1	TabletOral	Sandoz Inc	0781-8113	00781-8113-0100781-8113-05
Bumetanide	Bumetanide 2 mg/1	TabletOral	Sandoz Inc	0781-8160	00781-8160-01
Bumetanide	Bumetanide .25 mg/mL	Injection, SolutionIntramuscular, Intravenous	Civica, Inc.	72572-210	72572-0210-10
Bumetanide	Bumetanide .25 mg/mL	Injection, SolutionIntramuscular, Intravenous	Civica, Inc.	72572-211	72572-0211-10
Bumetanide	Bumetanide .25 mg/mL	InjectionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-5131	55154-5131-05
Bumetanide	Bumetanide 1 mg/1	TabletOral	NorthStar Rx LLC	72603-900	72603-0900-0172603-0900-02
Bumetanide	Bumetanide .5 mg/1	TabletOral	NorthStar Rx LLC	72603-889	72603-0889-01
Bumetanide	Bumetanide 2 mg/1	TabletOral	NorthStar Rx LLC	72603-901	72603-0901-0172603-0901-02
Bumetanide	Bumetanide .25 mg/mL	Injection, SolutionIntramuscular, Intravenous	Anthea Pharma Private Limited	83854-007	83854-0007-10

All 123 Bumetanide NDCs

Other NDCs under ANDA 074700

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074700
Product	Strength	Form · route	Labeler	Product NDC
Bumetanide	Bumetanide 1 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-288
Bumetanide	Bumetanide 1 mg/1	TabletOral	Sandoz Inc	0781-8113
Bumetanide	Bumetanide 1 mg/1	TabletOral	Proficient Rx LP	82804-119
Bumetanide	Bumetanide 2 mg/1	TabletOral	Sandoz Inc	0781-8160
Bumetanide	Bumetanide 1 mg/1	TabletOral	Bryant Ranch Prepack	63629-4968
Bumetanide	Bumetanide .5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2195
Bumetanide	Bumetanide 1 mg/1	TabletOral	Bryant Ranch Prepack	72162-2196
Bumetanide	Bumetanide 2 mg/1	TabletOral	Bryant Ranch Prepack	72162-2197
Bumetanide	Bumetanide 1 mg/1	TabletOral	Bryant Ranch Prepack	71335-2670
Bumetanide	Bumetanide .5 mg/1	TabletOral	Sandoz Inc	0781-8099
Bumetanide	Bumetanide 1 mg/1	TabletOral	Bryant Ranch Prepack	71335-2920
Bumetanide	Bumetanide 2 mg/1	TabletOral	Bryant Ranch Prepack	71335-2705
Bumetanide	Bumetanide .5 mg/1	TabletOral	A-S Medication Solutions	50090-6308
Bumetanide	Bumetanide 2 mg/1	TabletOral	A-S Medication Solutions	50090-6304
Bumetanide	Bumetanide 1 mg/1	TabletOral	Sandoz Inc	0185-0129
Bumetanide	Bumetanide 2 mg/1	TabletOral	Sandoz Inc	0185-0130
Bumetanide	Bumetanide 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-4387
Bumetanide	Bumetanide 1 mg/1	TabletOral	A-S Medication Solutions	50090-6345
Bumetanide	Bumetanide 2 mg/1	TabletOral	Bryant Ranch Prepack	71335-2998