Prescription drug · ANDA
Nitroglycerin NDC 85766-116
Nitroglycerin .4 mg/1 · Tablet · Sublingual · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-116-00 | 85766011600 | 4 BOTTLE in 1 CARTON (85766-116-00) / 25 TABLET in 1 BOTTLEMarketed from Oct 31, 2025 | |
| 85766-116-01 | 85766011601 | 1 BOTTLE in 1 CARTON (85766-116-01) / 100 TABLET in 1 BOTTLEMarketed from Oct 31, 2025 | |
| 85766-116-10 | 85766011610 | 10 TABLET in 1 BOTTLE (85766-116-10)Marketed from Oct 31, 2025 | |
| 85766-116-20 | 85766011620 | 20 TABLET in 1 BOTTLE (85766-116-20)Marketed from Oct 31, 2025 | |
| 85766-116-25 | 85766011625 | 25 TABLET in 1 BOTTLE (85766-116-25)Marketed from Oct 31, 2025 | |
| 85766-116-30 | 85766011630 | 30 TABLET in 1 BOTTLE (85766-116-30)Marketed from Oct 31, 2025 | |
| 85766-116-60 | 85766011660 | 60 TABLET in 1 BOTTLE (85766-116-60)Marketed from Oct 31, 2025 | |
| 85766-116-90 | 85766011690 | 90 TABLET in 1 BOTTLE (85766-116-90)Marketed from Oct 31, 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 — .4 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- Sportpharm LLCNDC labeler code 85766
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211604
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 85766-116_50321bf1-3be4-6a2b-e063-6394a90aa218SPL ID 50321bf1-3be4-6a2b-e063-6394a90aa218SPL set ID 84739085-81df-4a43-8456-c9edfbf971e9RxCUI 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
N485766011600followed by a unit qualifier and the quantityPackage 85766-0116-00. 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 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.
About NDC 85766-116
- What is NDC 85766-116?
- 85766-116 is the product NDC for Nitroglycerin, Nitroglycerin .4 mg/1 tablet, listed with the FDA by Sportpharm LLC. It has 8 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?
- Sportpharm LLC, NDC labeler code 85766. 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.
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/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 | Prasco Laboratories | 66993-241 | 66993-0241-4166993-0241-50 |
Other NDCs under ANDA 211604
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 | NuCare Pharmaceuticals,Inc. | 68071-2941 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Redpharm Drug | 67296-2177 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Natco Pharma USA LLC | 69339-174 |
| Nitroglycerin | Nitroglycerin .3 mg/1 | TabletSublingual | Natco Pharma USA LLC | 69339-173 |
| Nitroglycerin | Nitroglycerin .6 mg/1 | TabletSublingual | Natco Pharma USA LLC | 69339-175 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Proficient Rx LP | 82804-077 |
| Nitroglycerin | Nitroglycerin .4 mg/1 | TabletSublingual | Medical Purchasing Solutions, LL | 71872-7300 |