NDC codes

FDA NDC Directory
Product NDC (as listed)59651-657Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0657Add 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
59651-657-00596510657001 BOTTLE in 1 CARTON (59651-657-00) / 100 TABLET in 1 BOTTLEMarketed from Oct 26, 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)
Nitroglycerin
Generic name (nonproprietary)
nitroglycerin
Active ingredients
Nitroglycerin — .3 mg/1
Dosage form
Tablet
Route
Sublingual
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217879
Marketing start
Listing expires
Other FDA classes
Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers
Product ID 59651-657_26c314ea-077e-490b-826b-2aafcb6e9564SPL ID 26c314ea-077e-490b-826b-2aafcb6e9564SPL set ID 26c314ea-077e-490b-826b-2aafcb6e9564RxCUI 198038, 198039, 198040UNII G59M7S0WS3
Pharmacologic class
Nitrate Vasodilator

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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N459651065700 followed by a unit qualifier and the quantity

Package 59651-0657-00. 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 .

Indications (excerpt from the label)

Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-657

What is NDC 59651-657?
59651-657 is the product NDC for Nitroglycerin, Nitroglycerin .3 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nitroglycerin.
What is the active ingredient?
Nitroglycerin.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nitroglycerin?
67 other product NDCs are listed under this name. See all Nitroglycerin 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 Nitroglycerin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NitroglycerinNitroglycerin 4 mg/gOintmentRectalPadagis Israel Pharmaceuticals Ltd45802-93245802-0932-94
NitroglycerinNitroglycerin 4 mg/gOintmentRectalBryant Ranch Prepack72162-264372162-2643-03
NitroglycerinNitroglycerin 4 mg/gOintmentRectalSolaris Pharma Corporation73473-50073473-0500-30
NitroglycerinNitroglycerin .6 mg/1TabletSublingualSolco Healthcare U.S., LLC43547-98743547-0987-0443547-0987-10
NitroglycerinNitroglycerin .3 mg/1TabletSublingualSolco Healthcare U.S., LLC43547-98543547-0985-0443547-0985-10
NitroglycerinNitroglycerin .4 mg/1TabletSublingualSolco Healthcare U.S., LLC43547-98643547-0986-0443547-0986-10
NitroglycerinNitroglycerin 20 mg/gOintmentTopicalEncube Ethicals, Inc.21922-05421922-0054-0521922-0054-47
nitroglycerinNitroglycerin .4 mg/1TabletSublingualREMEDYREPACK INC.70518-427770518-4277-0070518-4277-01
NitroglycerinNitroglycerin 4 mg/gOintmentRectalEncube Ethicals, Inc.21922-04821922-0048-05
NitroglycerinNitroglycerin 400 ug/1SprayOralPrasco Laboratories66993-24166993-0241-4166993-0241-50

All 68 Nitroglycerin NDCs

Other NDCs under ANDA 217879

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

FDA NDC Directory listings under ANDA 217879
ProductStrengthForm · routeLabelerProduct NDC
NitroglycerinNitroglycerin .4 mg/1TabletSublingualAurobindo Pharma Limited59651-658
NitroglycerinNitroglycerin .6 mg/1TabletSublingualAurobindo Pharma Limited59651-659

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