NITRO-BID
- Product NDC
- 0168-0326
- 11-digit product format
- 001680326
- Labeler code
- 0168
- Product ID
- 0168-0326_c0c4328d-68fc-4fea-87aa-93b385f3e7a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitroglycerin
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- E. FOUGERA & CO., A division of Nycomed US Inc.
- Application
- ANDA087355
- Marketing category
- ANDA
- Marketing start
- 2009-08-15
- Marketing end
- 0000-00-00
- Substance
- NITROGLYCERIN
- Active strength
- 20 mg/g
- Pharmacologic classes
- Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0168-0326 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 0168-0326 | 0168-0326-08 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 0168-0326 | 0168-0326-30 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 0168-0326 | 0168-0326-60 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087355-001 | NITROGLYCERIN | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | AB | RLD, RS | 1988-07-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A087355-001 | 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 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | AB | RLD, RS | 1988-07-08 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | AB | RLD, RS | 1988-07-08 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | AB | RLD, RS | 1988-07-08 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RLD, RS | 1988-07-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087355-001 | NITROGLYCERIN | 2% | OINTMENT / TRANSDERMAL | RS | 1988-07-08 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A087355-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087355-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A087355-001 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A087355-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NITRO-BID | NITROGLYCERIN | Savage Laboratories a division of Fougera Pharmaceuticals, LLC | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 2026-01-28 | Warnings, Adverse reactions | 087355 ANDA087355 |
| NITROGLYCERIN | NITROGLYCERIN | HF Acquisition Co LLC, DBA HealthFirst | 7da79fdf-0969-1ddd-e053-2991aa0a3ec4 | 2022-12-09 | Warnings, Adverse reactions | 087355 ANDA087355 |