NITROGLYCERIN
- Product NDC
- 21922-048
- 11-digit product format
- 219220048
- Labeler code
- 21922
- Product ID
- 21922-048_cc9f786f-9281-420d-876a-e043592cc148
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitroglycerin
- Dosage form
- OINTMENT
- Route
- RECTAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA216452
- Marketing category
- ANDA
- Marketing start
- 2024-12-17
- 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 |
|---|
| 21922-048-05 | NITROGLYCERIN | 1 in 1 CARTON | OINTMENT | 1 | | 6 |
| 21922-048-05 | NITROGLYCERIN | 30 g in 1 TUBE | OINTMENT | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-048 | NITROGLYCERIN OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED] | 5 | Current NDC, 2 package rows | 20241219_7bcead76-a90f-4140-9c73-4339d981a084.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 |
|---|
| 21922-048-05 | 21922004805 | 1 TUBE in 1 CARTON (21922-048-05) / 30 g in 1 TUBE | 1 tube | 2024-12-17 | No | No | Current |