Prescription drug · NDA
Nitroglycerin In Dextrose (Nitroglycerin) NDC 0338-1051
Nitroglycerin 40 mg/100mL · Injection · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-1051-02 | 00338105102 | 12 BOTTLE, GLASS in 1 BOX (0338-1051-02) / 250 mL in 1 BOTTLE, GLASSMarketed from Dec 29, 1989 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 In Dextrose
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 40 mg/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Baxter Healthcare CompanyNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019970
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 0338-1051_b89cb9ff-d275-465b-b70b-d8e2e9406435SPL ID b89cb9ff-d275-465b-b70b-d8e2e9406435SPL set ID 457a026c-ebce-4701-9deb-2d7652759a99RxCUI 312004, 1868494, 1868562UNII 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400338105102followed by a unit qualifier and the quantityPackage 00338-1051-02. 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 in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension.
Excerpt only. Read the full label for complete information.
About NDC 0338-1051
- What is NDC 0338-1051?
- 0338-1051 is the product NDC for Nitroglycerin In Dextrose (nitroglycerin), Nitroglycerin 40 mg/100mL injection, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitroglycerin In Dextrose (Nitroglycerin).
- What is the active ingredient?
- Nitroglycerin.
- Who is the labeler?
- Baxter Healthcare Company, NDC labeler code 0338. 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 In Dextrose?
- 4 other product NDCs are listed under this name. See all Nitroglycerin In Dextrose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitroglycerin In Dextrose 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 In Dextrosenitroglycerin, dextrose | Nitroglycerin 20 mg/100mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1332 | 51662-1332-01 |
| Nitroglycerin In Dextrosenitroglycerin | Nitroglycerin 10 mg/100mL | InjectionIntravenous | Baxter Healthcare Company | 0338-1047 | 00338-1047-02 |
| Nitroglycerin In Dextrosenitroglycerin | Nitroglycerin 20 mg/100mL | InjectionIntravenous | Baxter Healthcare Company | 0338-1049 | 00338-1049-02 |
| Nitroglycerin In Dextrosenitroglycerin | Nitroglycerin 10 mg/100mL | InjectionIntravenous | ProPharma Distribution | 84549-147 | 84549-0147-02 |
Other NDCs under NDA 019970
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 In Dextrosenitroglycerin | Nitroglycerin 10 mg/100mL | InjectionIntravenous | Baxter Healthcare Company | 0338-1047 |
| Nitroglycerin In Dextrosenitroglycerin | Nitroglycerin 20 mg/100mL | InjectionIntravenous | Baxter Healthcare Company | 0338-1049 |
| Nitroglycerin In Dextrosenitroglycerin, dextrose | Nitroglycerin 20 mg/100mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1332 |
| Nitroglycerin In Dextrosenitroglycerin | Nitroglycerin 10 mg/100mL | InjectionIntravenous | ProPharma Distribution | 84549-147 |