Nitroglycerin
- Product NDC
- 85766-294
- 11-digit product format
- 857660294
- Labeler code
- 85766
- Product ID
- 85766-294_5c9cfb7f-d01d-460d-e063-6394a90a3d12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitroglycerin
- Dosage form
- SPRAY
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- NDA018705
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2024-12-02
- Substance
- NITROGLYCERIN
- Active strength
- 400 ug/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018705-001 | NITROLINGUAL | NITROGLYCERIN | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | ||
| N018705-002 | NITROLINGUAL PUMPSPRAY | NITROGLYCERIN | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018705-002 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018705-001 | NITROLINGUAL | 0.4MG/SPRAY | AEROSOL / SUBLINGUAL | 1985-10-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018705-002 | NITROLINGUAL PUMPSPRAY | 0.4MG/SPRAY | SPRAY, METERED / SUBLINGUAL | AB | RLD, RS | 1997-01-10 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018705-002 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N018705-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N018705-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018705-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018705-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018705-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018705-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018705-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018705-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018705-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018705-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018705-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018705-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018705-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018705-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018705-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018705-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018705-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018705-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018705-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018705-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018705-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018705-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018705-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N018705-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N018705-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018705-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018705-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018705-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018705-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018705-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N018705-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N018705-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018705-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018705-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018705-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018705-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N018705-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N018705-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018705-002 | AB | 1 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018705-002 | 7872049 | 2029-03-12 | U-2223 | Drug product | 2012-04-11 | 3a93d1ddd44b… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nitroglycerin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NITROGLYCERIN | 400 ug/1 |
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 |
|---|---|---|---|---|---|---|
| NITROGLYCERIN LINGUAL | NITROGLYCERIN | Allegis Pharmaceuticals, LLC | fadd07b7-189b-4678-ad0f-bf1e4d3d1300 | 2025-12-17 | Warnings, Adverse reactions | 018705 NDA018705 |
| NITROGLYCERIN | NITROGLYCERIN | HF Acquisition Co LLC, DBA HealthFirst | 422b4713-9531-f1bf-e063-6294a90ada2b | 2025-10-27 | Warnings, Adverse reactions | 018705 NDA018705 |
| NITROLINGUAL | NITROGLYCERIN | INDEPENDENCE PHARMACEUTICALS, LLC | d19b5f51-ca85-48d6-9ccd-8ae26249cdc3 | 2024-05-13 | Warnings, Adverse reactions | 018705 NDA018705 |
| NITROGLYCERIN LINGUAL | NITROGLYCERIN LINGUAL | HF Acquisition Co LLC, DBA HealthFirst | a8eb91f6-7f2e-7d57-e053-2995a90a3893 | 2024-02-22 | Warnings, Adverse reactions | 018705 NDA018705 |
| Nitroglycerin | NITROGLYCERIN | Prasco Laboratories | f9731c86-34b0-42a2-8b39-eca907e02e74 | 2024-01-01 | Warnings, Adverse reactions | 018705 NDA018705 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85766-294-05 | 85766029405 | 1 BOTTLE, SPRAY in 1 CARTON (85766-294-05) / 60 SPRAY in 1 BOTTLE, SPRAY | 2026-09-29 | No | No | Current |
| 85766-294-14 | 85766029414 | 1 BOTTLE, SPRAY in 1 CARTON (85766-294-14) / 200 SPRAY in 1 BOTTLE, SPRAY | 2026-09-29 | No | No | Current |