NITROLINGUAL
- Product NDC
- 28595-550
- 11-digit product format
- 285950550
- Labeler code
- 28595
- Product ID
- 28595-550_462b2d3f-67b1-c393-e063-6294a90a208a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitroglycerin
- Dosage form
- SPRAY
- Route
- ORAL
- Labeler
- Allegis Pharmaceuticals, LLC
- Application
- NDA018705
- Marketing category
- NDA
- Marketing start
- 2019-07-01
- Marketing end
- 2026-05-31
- Substance
- NITROGLYCERIN
- Active strength
- 400 ug/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 28595-550-12 | NITROLINGUAL | 1 in 1 CARTON | SPRAY | 1 | | 3 |
| 28595-550-12 | NITROLINGUAL | 200 in 1 BOTTLE, SPRAY | SPRAY | 200 | | 3 |
| 28595-550-49 | NITROLINGUAL | 60 in 1 BOTTLE, SPRAY | SPRAY | 60 | | 3 |
| 28595-550-49 | NITROLINGUAL | 1 in 1 CARTON | SPRAY | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 28595-550 | NITROLINGUAL (NITROGLYCERIN) SPRAY [ALLEGIS PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240110_d8765f0e-1fe9-4e2a-9138-186c093edceb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 28595-550-12 | 28595055012 | 1 BOTTLE, SPRAY in 1 CARTON (28595-550-12) / 200 SPRAY in 1 BOTTLE, SPRAY | 2019-07-01 | 2026-05-31 | No | No | Current |
| 28595-550-49 | 28595055049 | 1 BOTTLE, SPRAY in 1 CARTON (28595-550-49) / 60 SPRAY in 1 BOTTLE, SPRAY | 2019-07-01 | 2026-05-31 | No | No | Current |