Prescription drug · UNAPPROVED DRUG OTHER
Nitro-Time (Nitroglycerin) NDC 49483-221
Nitroglycerin 2.5 mg/1 · Capsule · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-221-06 | 4948302210649483022106 | 60 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-06)Marketed from Oct 9, 2018 | |
| 49483-221-10 | 4948302211049483022110 | 100 CAPSULE in 1 BOTTLE, PLASTIC (49483-221-10)Marketed from Oct 9, 2018 |
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)
- Nitro-Time
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 2.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INCNDC labeler code 49483
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 49483-221_51ed5c69-89ac-27ed-e063-6394a90acca1SPL ID 51ed5c69-89ac-27ed-e063-6394a90acca1SPL set ID 3c11c1c2-8e62-4f63-8293-2f8b8d845f7eRxCUI 312013, 312018, 312020UNII G59M7S0WS3UPC 0349483221107, 0349483223101, 0349483222067
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N449483022106followed by a unit qualifier and the quantityPackage 49483-0221-06. 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 Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral 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 49483-221
- What is NDC 49483-221?
- 49483-221 is the product NDC for Nitro-Time (nitroglycerin), Nitroglycerin 2.5 mg/1 capsule, listed with the FDA by TIME CAP LABORATORIES, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitro-Time (Nitroglycerin).
- What is the active ingredient?
- Nitroglycerin.
- Who is the labeler?
- TIME CAP LABORATORIES, INC, NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitro-Time?
- 2 other product NDCs are listed under this name. See all Nitro-Time NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitro-Time products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitro-Timenitroglycerin | Nitroglycerin 6.5 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-222 | 49483-0222-0649483-0222-10 |
| Nitro-Timenitroglycerin | Nitroglycerin 9 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-223 | 49483-0223-0649483-0223-10 |