Nitroglycerin
- Product NDC
- 70518-4232
- 11-digit product format
- 705184232
- Labeler code
- 70518
- Product ID
- 70518-4232_40062900-8718-646e-e063-6394a90a9e33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitroglycerin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA072034
- Marketing category
- ANDA
- Marketing start
- 2024-11-14
- Substance
- NITROGLYCERIN
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A072034-001 | NITROGLYCERIN | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A072034-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | RS | 1988-05-24 | f41ea6bd6efb… |
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 | 5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G59M7S0WS3 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 237205 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b8af0974-33ea-4dd5-9ff7-3b61272aeb25 | Available on FDA.report |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-4232-0 | Nitroglycerin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 2 | |
| 70518-4232-1 | Nitroglycerin | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-4232 | NITROGLYCERIN INJECTION, SOLUTION [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20241121_b8af0974-33ea-4dd5-9ff7-3b61272aeb25.zip |
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 | NITROGLYCERIN | REMEDYREPACK INC. | b8af0974-33ea-4dd5-9ff7-3b61272aeb25 | 2026-09-01 | Warnings, Adverse reactions | 072034 ANDA072034 70518-4232 |
| Nitroglycerin | NITROGLYCERIN | Henry Schein, Inc. | 578d8159-5ec6-457f-b4a8-9add624d43a8 | 2025-11-06 | Warnings, Adverse reactions | 072034 ANDA072034 |
| NITROGLYCERIN | NITROGLYCERIN | HF Acquisition Co LLC, DBA HealthFirst | 9453bd8b-5d54-5dc8-e053-2995a90a95b2 | 2025-06-16 | Warnings, Adverse reactions | 072034 ANDA072034 |
| Nitroglycerin | NITROGLYCERIN | American Regent, Inc. | 8c52cdf6-87be-4719-b105-f08be096d462 | 2021-07-22 | Warnings, Adverse reactions | 072034 ANDA072034 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 237205 | nitroglycerin 50 MG in 10 ML Injection | PSN | b8af0974-33ea-4dd5-9ff7-3b61272aeb25 | 2 |
| 237205 | 10 ML nitroglycerin 5 MG/ML Injection | SCD | b8af0974-33ea-4dd5-9ff7-3b61272aeb25 | 2 |
| 237205 | 10 ML NTG 5 MG/ML Injection | SY | b8af0974-33ea-4dd5-9ff7-3b61272aeb25 | 2 |
| 237205 | 10 ML TNG 5 MG/ML Injection | SY | b8af0974-33ea-4dd5-9ff7-3b61272aeb25 | 2 |
| 237205 | nitroglycerin 50 MG per 10 ML Injection | SY | b8af0974-33ea-4dd5-9ff7-3b61272aeb25 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-4232-0 | 70518423200 | 25 VIAL, SINGLE-DOSE in 1 TRAY (70518-4232-0) / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4232-1) | 2024-11-14 | No | No | Current | |
| 70518-4232-1 | 70518423201 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | Historical |