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NDC 49483-0222-06 NITRO-TIME 6.5 mg/1 Details
NITRO-TIME 6.5 mg/1
NITRO-TIME is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC. The primary component is NITROGLYCERIN.
MedlinePlus Drug Summary
Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). It is also used just before activities that may cause episodes of angina in order to prevent the angina from occurring. Nitroglycerin is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not need to work as hard and therefore does not need as much oxygen.
Related Packages: 49483-0222-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nitroglycerin Sublingual
Product Information
| NDC | 49483-0222 |
|---|---|
| Product ID | 49483-222_77d1e7a4-7b10-2f06-e053-2991aa0a2527 |
| Associated GPIs | 32100030000215 |
| GCN Sequence Number | 000456 |
| GCN Sequence Number Description | nitroglycerin CAPSULE ER 6.5 MG ORAL |
| HIC3 | A7B |
| HIC3 Description | VASODILATORS,CORONARY |
| GCN | 01682 |
| HICL Sequence Number | 000159 |
| HICL Sequence Number Description | NITROGLYCERIN |
| Brand/Generic | Generic |
| Proprietary Name | NITRO-TIME |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | NITROGLYCERIN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 6.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | NITROGLYCERIN |
| Labeler Name | TIME CAP LABORATORIES, INC |
| Pharmaceutical Class | Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49483-0222-06 (49483022206)
| NDC Package Code | 49483-222-06 |
|---|---|
| Billing NDC | 49483022206 |
| Package | 60 CAPSULE in 1 BOTTLE, PLASTIC (49483-222-06) |
| Marketing Start Date | 2018-10-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3c11c1c2-8e62-4f63-8293-2f8b8d845f7e Details
HOW SUPPLIED:
HOW SUPPLIED
HOW SUPPLIED
INGREDIENTS AND APPEARANCE
| NITRO-TIME
nitroglycerin capsule |
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| Labeler - TIME CAP LABORATORIES, INC (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| TIME CAP LABORATORIES, INC | 037052099 | manufacture(49483-221, 49483-222, 49483-223) | |
Revised: 10/2018
Document Id: 77d1e7a4-7b10-2f06-e053-2991aa0a2527
Set id: 3c11c1c2-8e62-4f63-8293-2f8b8d845f7e
Version: 4
Effective Time: 20181009