Prescription drug · ANDA
Nitroglycerin NDC 21922-054
Nitroglycerin 20 mg/g · Ointment · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-054-05 | 2192200540521922005405 | 1 TUBE in 1 CARTON (21922-054-05) / 30 g in 1 TUBEMarketed from Apr 16, 2025 | |
| 21922-054-47 | 2192200544721922005447 | 48 POUCH in 1 CARTON (21922-054-47) / 1 g in 1 POUCH (21922-054-59)Marketed from Apr 16, 2025 |
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 — 20 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218235
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 21922-054_a46f7681-b936-40d3-8c36-e9bb5d655d73SPL ID a46f7681-b936-40d3-8c36-e9bb5d655d73SPL set ID c17c997b-0e90-4105-888b-2de22d2bf697RxCUI 242946UNII G59M7S0WS3UPC 0321922054057, 0321922054477
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N421922005405followed by a unit qualifier and the quantityPackage 21922-0054-05. 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)
INDICATIONS AND USAGE Nitroglycerin ointment USP, 2% is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Excerpt only. Read the full label for complete information.
About NDC 21922-054
- What is NDC 21922-054?
- 21922-054 is the product NDC for Nitroglycerin, Nitroglycerin 20 mg/g ointment, listed with the FDA by Encube Ethicals, Inc.. It has 2 package NDCs, 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.
Related NDCs: other Nitroglycerin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Padagis Israel Pharmaceuticals Ltd | 45802-932 | 45802-0932-94 |
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Bryant Ranch Prepack | 72162-2643 | 72162-2643-03 |
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Solaris Pharma Corporation | 73473-500 | 73473-0500-30 |
| Nitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Solco Healthcare U.S., LLC | 43547-985 | 43547-0985-0443547-0985-10 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Solco Healthcare U.S., LLC | 43547-986 | 43547-0986-0443547-0986-10 |
| Nitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Solco Healthcare U.S., LLC | 43547-987 | 43547-0987-0443547-0987-10 |
| nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-4277 | 70518-4277-0070518-4277-01 |
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Encube Ethicals, Inc. | 21922-048 | 21922-0048-05 |
| Nitroglycerin | Nitroglycerin 400 ug/1 | SprayOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1672 | 51662-1672-01 |
| Nitroglycerin | Nitroglycerin 4 mg/g | OintmentRectal | Trupharma, LLC | 52817-835 | 52817-0835-30 |