NDC codes

FDA NDC Directory
Product NDC (as listed)21922-048Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21922-0048Add 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
21922-048-0521922004805219220048051 TUBE in 1 CARTON (21922-048-05) / 30 g in 1 TUBEMarketed from Dec 17, 2024

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 — 4 mg/g
Dosage form
Ointment
Route
Rectal
Labeler
Encube Ethicals, Inc.NDC labeler code 21922
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216452
Marketing start
Listing expires
Other FDA classes
Nitrates (Chemical structure)Vasodilation (Physiologic effect)
Identifiers
Product ID 21922-048_cc9f786f-9281-420d-876a-e043592cc148SPL ID cc9f786f-9281-420d-876a-e043592cc148SPL set ID 7bcead76-a90f-4140-9c73-4339d981a084RxCUI 1114466UNII 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 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.

NDC on a medical claim

N421922004805 followed by a unit qualifier and the quantity

Package 21922-0048-05. 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 .

Indications (excerpt from the label)

Nitroglycerin ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. Nitroglycerin ointment is a nitrate vasodilator indicated for the treatment of moderate to severe pain associated with chronic anal fissure ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 21922-048

What is NDC 21922-048?
21922-048 is the product NDC for Nitroglycerin, Nitroglycerin 4 mg/g ointment, listed with the FDA by Encube Ethicals, Inc.. 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?
Encube Ethicals, Inc., NDC labeler code 21922. 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?
69 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 .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 .6 mg/1TabletSublingualSolco Healthcare U.S., LLC43547-98743547-0987-0443547-0987-10
NitroglycerinNitroglycerin 20 mg/gOintmentTopicalEncube Ethicals, Inc.21922-05421922-0054-0521922-0054-47
nitroglycerinNitroglycerin .4 mg/1TabletSublingualREMEDYREPACK INC.70518-427770518-4277-0070518-4277-01
NitroglycerinNitroglycerin 400 ug/1SprayOralHF Acquisition Co LLC, DBA HealthFirst51662-167251662-1672-01
NitroglycerinNitroglycerin 4 mg/gOintmentRectalTrupharma, LLC52817-83552817-0835-30

All 70 Nitroglycerin NDCs

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