Nitrostat
- Product NDC
- 68071-1720
- 11-digit product format
- 680711720
- Labeler code
- 68071
- Product ID
- 68071-1720_bb17d441-0ecb-f7f6-e053-2a95a90a4679
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitroglycerin
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- NuCare Pharmaceuticals,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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68071-1720 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 68071-1720 | 68071-1720-5 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-1720-5 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-1720-5 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-1720-5 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-1720-5 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-1720-5 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-1720-5 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68071-1720-5 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 68071-1720-5 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 68071-1720-5 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 68071-1720-5 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021134-001 | NITROSTAT | NITROGLYCERIN | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 |
| N021134-002 | NITROSTAT | NITROGLYCERIN | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 |
| N021134-003 | NITROSTAT | NITROGLYCERIN | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021134-001 | AB |
| N021134-002 | AB |
| N021134-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021134-002 | NITROSTAT | 0.4MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021134-003 | NITROSTAT | 0.6MG | TABLET / SUBLINGUAL | AB | RLD, RS | 2000-05-01 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021134-001 | NITROSTAT | 0.3MG | TABLET / SUBLINGUAL | AB | RLD | 2000-05-01 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021134-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021134-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021134-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021134-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021134-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021134-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021134-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021134-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021134-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021134-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021134-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021134-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021134-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021134-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021134-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021134-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021134-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021134-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021134-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021134-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021134-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021134-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021134-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021134-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021134-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021134-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021134-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021134-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021134-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021134-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021134-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021134-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021134-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021134-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021134-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021134-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021134-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021134-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021134-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021134-001 | AB | 1 | 8072bd15b7f6… |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-08-20 | Nitrostat ® (Nitroglycerin Sublingual Tablets, USP) |
| 2023-01-30 | Nitrostat ® (Nitroglycerin Sublingual Tablets, USP) |
| 2021-02-11 | Nitrostat ® (Nitroglycerin Sublingual Tablets, USP) |
| 2021-01-29 | Nitrostat ® (Nitroglycerin Sublingual Tablets, USP) |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NITROSTAT | NITROGLYCERIN TABLET | Henry Schein, Inc. | 5265648f-3062-48a2-a4e3-fea1207807a8 | 2025-11-06 | Warnings, Adverse reactions | 021134 NDA021134 |
| NITROGLYCERIN | NITROGLYCERIN | Mylan Pharmaceuticals Inc. | 041f127e-5166-4484-bc1a-0a373d1187ae | 2024-10-15 | Warnings, Adverse reactions | 021134 NDA021134 |
| NITROSTAT | NITROGLYCERIN | A-S Medication Solutions | f7059ff7-bf74-48b4-811d-6eb1c26bfd8b | 2024-08-05 | Warnings, Adverse reactions | 021134 NDA021134 |
| Nitrostat | NITROGLYCERIN | Viatris Specialty LLC | 9a52da75-d0af-4237-96c0-0b12adfa8636 | 2023-02-15 | Warnings, Adverse reactions | 021134 NDA021134 |
| Nitrostat | NITROGLYCERIN | Proficient Rx LP | 6fe3965f-0dd8-4bae-9771-de25074cb1b0 | 2019-11-01 | Warnings, Adverse reactions | 021134 NDA021134 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-1720-5 | 68071172005 | 25 TABLET in 1 BOTTLE (68071-1720-5) | 25 tablet | 2018-01-02 | 0000-00-00 | No | No | Current |