NITROLINGUAL
- Product NDC
- 21724-100
- 11-digit product format
- 217240100
- Labeler code
- 21724
- Product ID
- 21724-100_71e0fc6a-41c8-4463-95c3-17335702a210
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitroglycerin
- Dosage form
- SPRAY
- Route
- ORAL
- Labeler
- INDEPENDENCE PHARMACEUTICALS, LLC
- Application
- NDA018705
- Marketing category
- NDA
- Marketing start
- 2024-12-02
- Substance
- NITROGLYCERIN
- Active strength
- 400 ug/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
- NITROLINGUAL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROGLYCERIN | 400 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G59M7S0WS3 |
| Rxcui | 705129, 995019 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21724-100-41 | NITROLINGUAL | 1 in 1 CARTON | SPRAY | 1 | | 1 |
| 21724-100-41 | NITROLINGUAL | 200 in 1 BOTTLE, SPRAY | SPRAY | 200 | | 1 |
| 21724-100-50 | NITROLINGUAL | 60 in 1 BOTTLE, SPRAY | SPRAY | 60 | | 1 |
| 21724-100-50 | NITROLINGUAL | 1 in 1 CARTON | SPRAY | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21724-100 | NITROLINGUAL (NITROGLYCERIN) SPRAY [INDEPENDENCE PHARMACEUTICALS, LLC] | 1 | Current NDC, 4 package rows | 20241203_d19b5f51-ca85-48d6-9ccd-8ae26249cdc3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 21724-100-41 | 21724010041 | 1 BOTTLE, SPRAY in 1 CARTON (21724-100-41) / 200 SPRAY in 1 BOTTLE, SPRAY | 2024-12-02 | No | No | Current |
| 21724-100-50 | 21724010050 | 1 BOTTLE, SPRAY in 1 CARTON (21724-100-50) / 60 SPRAY in 1 BOTTLE, SPRAY | 2024-12-02 | No | No | Current |