NITROSTAT
- Product NDC
- 0404-9800
- 11-digit product format
- 004049800
- Labeler code
- 0404
- Product ID
- 0404-9800_32b2fbb8-8769-4399-9cb6-7183cb7072ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitroglycerin tablet
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Henry Schein, Inc.
- Application
- NDA021134
- Marketing category
- NDA
- Marketing start
- 2024-09-17
- Substance
- NITROGLYCERIN
- Active strength
- .4 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NITROSTAT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROGLYCERIN | .4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G59M7S0WS3 |
| Rxcui | 198039, 207346 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9800-01 | NITROSTAT | 1 in 1 BAG | TABLET | 1 | | 2 |
| 0404-9800-01 | NITROSTAT | 25 in 1 BOTTLE | TABLET | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9800 | NITROSTAT (NITROGLYCERIN TABLET) TABLET [HENRY SCHEIN, INC.] | 1 | Current NDC, 2 package rows | 20240919_5265648f-3062-48a2-a4e3-fea1207807a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9800-01 | 00404980001 | 1 BOTTLE in 1 BAG (0404-9800-01) / 25 TABLET in 1 BOTTLE | 1 bottle | 2024-09-17 | No | No | Historical |