Prescription drug · ANDA
nitroglycerin NDC 70518-4277
Nitroglycerin .4 mg/1 · Tablet · Sublingual · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4277-0 | 7051842770070518427700 | 1 BOTTLE in 1 CARTON (70518-4277-0) / 100 TABLET in 1 BOTTLEMarketed from Feb 5, 2025 | |
| 70518-4277-1 | 7051842770170518427701 | 4 BOTTLE in 1 CARTON (70518-4277-1) / 25 TABLET in 1 BOTTLEMarketed from Feb 8, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217970
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 70518-4277_5a94e6e0-a018-eb10-e063-6394a90a92f7SPL ID 5a94e6e0-a018-eb10-e063-6394a90a92f7SPL set ID 89da40c1-bab1-422e-b326-8ebcbdbc81f3RxCUI 198039UNII 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
N470518427700followed by a unit qualifier and the quantityPackage 70518-4277-00. 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 sublingual tablets are 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.
About NDC 70518-4277
- What is NDC 70518-4277?
- 70518-4277 is the product NDC for nitroglycerin, Nitroglycerin .4 mg/1 tablet, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 20 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-054 | 21922-0054-0521922-0054-47 |
| 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 |
Other NDCs under ANDA 217970
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Redpharm Drug | 67296-2313 |
| nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | NuCare Pharmaceuticals, Inc. | 68071-5338 |
| nitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Lifestar Pharma LLC | 70756-013 |
| nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Lifestar Pharma LLC | 70756-014 |
| nitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Lifestar Pharma LLC | 70756-016 |
| nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Medical Purchasing Solutions, LLC | 71872-7338 |
| nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Medical Purchasing Solutions, LLC. | 71872-7383 |
| nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | NorthStar RxLLC | 72603-266 |