NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7016Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7016Add 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 NDC11-digit (billing)PackageCopy
0904-7016-04009047016040090470160430 BLISTER PACK in 1 CARTON (0904-7016-04) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 18, 2017
0904-7016-06009047016060090470160650 BLISTER PACK in 1 CARTON (0904-7016-06) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 18, 2017
0904-7016-610090470166100904701661100 BLISTER PACK in 1 CARTON (0904-7016-61) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 18, 2017

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 — 1 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209724
Marketing start
Listing expires
Other FDA classes
Increased Diuresis at Loop of Henle (Physiologic effect)
Identifiers
Product ID 0904-7016_f2954eff-e0d7-49f4-8f3d-19566b5ce27aSPL ID f2954eff-e0d7-49f4-8f3d-19566b5ce27aSPL set ID a29cf117-00d0-4948-b646-013c8791ea39RxCUI 197418UNII 0Y2S3XUQ5H
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

N400904701604 followed by a unit qualifier and the quantity

Package 00904-7016-04. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Bumetanide tablets 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 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 0904-7016

What is NDC 0904-7016?
0904-7016 is the product NDC for Bumetanide, Bumetanide 1 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 3 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?
Major Pharmaceuticals, NDC labeler code 0904. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BumetanideBumetanide .5 mg/1TabletOralSandoz Inc0781-809900781-8099-0100781-8099-05
BumetanideBumetanide 1 mg/1TabletOralSandoz Inc0781-811300781-8113-0100781-8113-05
BumetanideBumetanide 2 mg/1TabletOralSandoz Inc0781-816000781-8160-01
BumetanideBumetanide .25 mg/mLInjection, SolutionIntramuscular, IntravenousCivica, Inc.72572-21072572-0210-10
BumetanideBumetanide .25 mg/mLInjection, SolutionIntramuscular, IntravenousCivica, Inc.72572-21172572-0211-10
BumetanideBumetanide .25 mg/mLInjectionIntramuscular, IntravenousCardinal Health 107, LLC55154-513155154-5131-05
BumetanideBumetanide 1 mg/1TabletOralNorthStar Rx LLC72603-90072603-0900-0172603-0900-02
BumetanideBumetanide .5 mg/1TabletOralNorthStar Rx LLC72603-88972603-0889-01
BumetanideBumetanide 2 mg/1TabletOralNorthStar Rx LLC72603-90172603-0901-0172603-0901-02
BumetanideBumetanide .25 mg/mLInjection, SolutionIntramuscular, IntravenousAnthea Pharma Private Limited83854-00783854-0007-10

All 123 Bumetanide NDCs

Other NDCs under ANDA 209724

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

FDA NDC Directory listings under ANDA 209724
ProductStrengthForm · routeLabelerProduct NDC
BumetanideBumetanide 1 mg/1TabletOralCardinal Health 107, LLC55154-3572
BumetanideBumetanide 1 mg/1TabletOralAmneal Pharmaceuticals NY LLC69238-1490
BumetanideBumetanide .5 mg/1TabletOralAmneal Pharmaceuticals NY LLC69238-1489
BumetanideBumetanide 2 mg/1TabletOralAmneal Pharmaceuticals NY LLC69238-1491
BumetanideBumetanide 2 mg/1TabletOralA-S Medication Solutions50090-5663
BumetanideBumetanide .5 mg/1TabletOralA-S Medication Solutions50090-5664
BumetanideBumetanide 1 mg/1TabletOralA-S Medication Solutions50090-5666
BumetanideBumetanide 1 mg/1TabletOralCardinal Health 107, LLC55154-4345
BumetanideBumetanide 1 mg/1TabletOralAvPAK50268-131
BumetanideBumetanide .5 mg/1TabletOralAvPAK50268-130
BumetanideBumetanide 2 mg/1TabletOralAvPAK50268-132

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