Nitrostat
- Product NDC
- 50090-0133
- 11-digit product format
- 500900133
- Labeler code
- 50090
- Product ID
- 50090-0133_c91c44cf-6aed-46f9-b8ac-a03c6dcef664
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitroglycerin
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- A-S Medication Solutions
- Application
- NDA021134
- Marketing category
- NDA
- Marketing start
- 2000-05-01
- Marketing end
- 0000-00-00
- Substance
- NITROGLYCERIN
- Active strength
- 0 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7480e90b-004b-ebe4-2243-4f2fefdd9e78 | Product name | 2 | 20260128 |
| 3f158398-73f2-4b90-47d1-5c60e8719a98 | Product name | 9 | 20250721 |
| ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0 | Product name | 2 | 20250117 |
| 00358076-c817-430b-b924-11d717dc307c | Product name | 1 | 20160718 |
| 669af5aa-14f3-3df7-f100-5f580ffd43c1 | Product name | 1 | 20140508 |
| 6ff3bab7-2dce-8bea-d7ce-54687f0c01fb | Product name | 1 | 20140508 |
| 8bb82a1c-d0d0-fc27-011f-172e545f0382 | Product name | 1 | 20140508 |
| cb03406d-e223-80bb-67d8-be80f9b6a4f2 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-0133-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-c2ce-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use NITROSTAT safely and effectively. See full prescribing information for NITROSTAT NITROSTAT (nitroglycerin) sublingual tablet Initial U.S. Approval: 1981 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-0133-0 | Nitrostat | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 50090-0133-0 | Nitrostat | 100 in 1 BOTTLE | TABLET | 100 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0133-0 | EA - Each | 50090-0133 | 9a5f5901-4490-47e3-92c5-22e6e05ce7fa | 1 | 2018-08-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NITROGLYCERIN | ACTIVE INGREDIENT | G59M7S0WS3 | NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| NITROGLYCERIN | ACTIVE MOIETY | G59M7S0WS3 | NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0133 | NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS] | 5 | Legacy NDC, 2 package rows | 20190402_cc481829-0b5a-4e8a-ab5b-cb44d6d2433b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | PSN | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 207346 | Nitrostat 0.4 MG Sublingual Tablet | PSN | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 207346 | nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat] | SBD | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | SCD | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 198039 | nitroglycerin 400 MCG Sublingual Tablet | SY | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 207346 | Nitrostat 0.4 MG Sublingual Tablet | SY | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 198039 | NTG 0.4 MG Sublingual Tablet | SY | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 207346 | NTG 0.4 MG Sublingual Tablet [Nitrostat] | SY | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 198039 | TNG 0.4 MG Sublingual Tablet | SY | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
| 207346 | TNG 0.4 MG Sublingual Tablet [Nitrostat] | SY | cc481829-0b5a-4e8a-ab5b-cb44d6d2433b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-0133-0 | 50090013300 | 1 BOTTLE in 1 CARTON (50090-0133-0) > 100 TABLET in 1 BOTTLE | 1 bottle | 2014-11-28 | 0000-00-00 | No | No | Current |