Nitrostat
- Product NDC
- 70385-2014
- 11-digit product format
- 703852014
- Labeler code
- 70385
- Product ID
- 70385-2014_8117f22a-3a4c-c5a3-e053-2991aa0ac782
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitroglycerin
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Sina Health Inc
- 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 |
|---|---|---|---|---|---|
| 70385-2014-1 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-34b2-f274-e053-dbdaa90a6471 | Nitrostat ® (Nitroglycerin Sublingual Tablets, USP) |
| 70385-2014-1 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-34b2-f274-e053-dbdaa90a6471 | Nitrostat ® (Nitroglycerin Sublingual Tablets, USP) |
| 70385-2014-1 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-34b2-f274-e053-dbdaa90a6471 | Nitrostat ® (Nitroglycerin Sublingual Tablets, USP) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70385-2014-1 | Nitrostat | 25 in 1 BOTTLE | TABLET | 25 | 3 | |
| 70385-2014-1 | Nitrostat | 1 in 1 BAG | TABLET | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70385-2014 | NITROSTAT (NITROGLYCERIN) TABLET [SINA HEALTH INC] | 3 | Legacy NDC, 2 package rows | 20190205_2d4165c3-169d-5af8-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | PSN | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 207346 | Nitrostat 0.4 MG Sublingual Tablet | PSN | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 207346 | nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat] | SBD | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | SCD | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 198039 | nitroglycerin 400 MCG Sublingual Tablet | SY | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 207346 | Nitrostat 0.4 MG Sublingual Tablet | SY | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 198039 | NTG 0.4 MG Sublingual Tablet | SY | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 207346 | NTG 0.4 MG Sublingual Tablet [Nitrostat] | SY | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 198039 | TNG 0.4 MG Sublingual Tablet | SY | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
| 207346 | TNG 0.4 MG Sublingual Tablet [Nitrostat] | SY | 2d4165c3-169d-5af8-e054-00144ff8d46c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 70385-2014-1 | 70385201401 | 25 in 1 BOTTLE | Historical |