NITROGLYCERIN
- Product NDC
- 52817-835
- 11-digit product format
- 528170835
- Labeler code
- 52817
- Product ID
- 52817-835_28693a60-dc7a-eacb-e063-6394a90ae222
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitroglycerin
- Dosage form
- OINTMENT
- Route
- RECTAL
- Labeler
- Trupharma, LLC
- Application
- ANDA212222
- Marketing category
- ANDA
- Marketing start
- 2024-12-02
- Substance
- NITROGLYCERIN
- Active strength
- 4 mg/g
- 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
- NITROGLYCERIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROGLYCERIN | 4 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G59M7S0WS3 |
| Rxcui | 1114466 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52817-835-30 | NITROGLYCERIN | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
| 52817-835-30 | NITROGLYCERIN | 30 g in 1 TUBE | OINTMENT | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52817-835 | NITROGLYCERIN OINTMENT [TRUPHARMA, LLC] | 1 | Current NDC, 2 package rows | 20241206_543ef8c8-d520-461b-bf6e-f8d8c277feec.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 |
|---|
| 52817-835-30 | 52817083530 | 1 TUBE in 1 CARTON (52817-835-30) / 30 g in 1 TUBE | 1 tube | 2024-12-02 | No | No | Current |