Nitrostat
- Product NDC
- 0071-0417
- 11-digit product format
- 000710417
- Labeler code
- 0071
- Product ID
- 0071-0417_b21bdc0d-86ca-4a5f-9695-a7a8064f5bed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitroglycerin
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Parke-Davis Div of Pfizer 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
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 | 0071-0417 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0071-0417 | 0071-0417-24 | D | Discontinued by firm | 2026-08-11 |
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… |
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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0071-0417-24 | EA - Each | 0071-0417 | a6f9c66c-9425-417f-85a8-523de6779eea | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198038 | nitroglycerin 0.3 MG Sublingual Tablet | PSN | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | PSN | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207331 | Nitrostat 0.3 MG Sublingual Tablet | PSN | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207346 | Nitrostat 0.4 MG Sublingual Tablet | PSN | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207331 | nitroglycerin 0.3 MG Sublingual Tablet [Nitrostat] | SBD | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207346 | nitroglycerin 0.4 MG Sublingual Tablet [Nitrostat] | SBD | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198038 | nitroglycerin 0.3 MG Sublingual Tablet | SCD | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198039 | nitroglycerin 0.4 MG Sublingual Tablet | SCD | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198038 | nitroglycerin 300 MCG Sublingual Tablet | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198039 | nitroglycerin 400 MCG Sublingual Tablet | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207331 | Nitrostat 0.3 MG Sublingual Tablet | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207346 | Nitrostat 0.4 MG Sublingual Tablet | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198038 | NTG 0.3 MG Sublingual Tablet | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207331 | NTG 0.3 MG Sublingual Tablet [Nitrostat] | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198039 | NTG 0.4 MG Sublingual Tablet | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207346 | NTG 0.4 MG Sublingual Tablet [Nitrostat] | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198038 | TNG 0.3 MG Sublingual Tablet | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207331 | TNG 0.3 MG Sublingual Tablet [Nitrostat] | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 198039 | TNG 0.4 MG Sublingual Tablet | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
| 207346 | TNG 0.4 MG Sublingual Tablet [Nitrostat] | SY | b32d82ee-7727-4501-a858-a8304135b11b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0071-0417-24 | 00071041724 | 1 BOTTLE in 1 CARTON (0071-0417-24) > 100 TABLET in 1 BOTTLE | 1 bottle | 2000-05-01 | 0000-00-00 | No | No | Current |