NITROGLYCERIN
- Product NDC
- 0713-0564
- 11-digit product format
- 007130564
- Labeler code
- 0713
- Product ID
- 0713-0564_11e6d0dd-d89a-7551-e063-6394a90a16ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitroglycerin
- Dosage form
- OINTMENT
- Route
- RECTAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA216103
- Marketing category
- ANDA
- Marketing start
- 2024-02-23
- 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 |
|---|
| 0713-0564-31 | NITROGLYCERIN | 30 g in 1 TUBE | OINTMENT | 30 | | 1 |
| 0713-0564-31 | NITROGLYCERIN | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0564 | NITROGLYCERIN OINTMENT [COSETTE PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20240224_ac908e70-9425-4e9c-8c67-7b2882b40204.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 |
|---|
| 0713-0564-31 | 00713056431 | 1 TUBE in 1 CARTON (0713-0564-31) / 30 g in 1 TUBE | 1 tube | 2024-02-23 | No | No | Current |