Prescription drug · ANDA
nitroglycerin NDC 68071-5338
Nitroglycerin .4 mg/1 · Tablet · Sublingual · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5338-5 | 6807153380568071533805 | 4 BOTTLE in 1 CARTON (68071-5338-5) / 25 TABLET in 1 BOTTLEMarketed from Oct 13, 2026 |
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
- NuCare Pharmaceuticals, Inc.NDC labeler code 68071
- 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 68071-5338_5dbd636c-3b77-364b-e063-6294a90ad624SPL ID 5dbd636c-3b77-364b-e063-6294a90ad624
- 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
N468071533805followed by a unit qualifier and the quantityPackage 68071-5338-05. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68071-5338
- What is NDC 68071-5338?
- 68071-5338 is the product NDC for nitroglycerin, Nitroglycerin .4 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, 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?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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/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 |
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 | REMEDYREPACK INC. | 70518-4277 |
| 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 |