Nitroglycerin

Product NDC: 0517-4810
11-digit product format: 005174810
Labeler code: 0517
Product ID: 0517-4810_ee83c8b9-c31a-4f32-9e9d-0370545204cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitroglycerin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: American Regent, Inc.
Application: ANDA072034
Marketing category: ANDA
Marketing start: 2003-03-04
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072034-001	NITROGLYCERIN	5MG/ML	INJECTABLE / INJECTION	RS	1988-05-24	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nitroglycerin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGLYCERIN	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G59M7S0WS3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
237205	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8c52cdf6-87be-4719-b105-f08be096d462	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0517-4810-01	Nitroglycerin	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		7
0517-4810-25	Nitroglycerin	25 in 1 TRAY	INJECTION, SOLUTION	25		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-4810-01	ML - Milliliter	0517-4810	416f8942-e0d3-49e4-9e3d-3e6c37affe19	1	2026-03-17
0517-4810-25	ML - Milliliter	0517-4810	d0d0b1d8-5d26-4f89-a790-deb2ff2199a8	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nitroglycerin	ACTIVE INGREDIENT	G59M7S0WS3	NITROGLYCERIN INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]	3
nitroglycerin	ACTIVE INGREDIENT	G59M7S0WS3	NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
Nitroglycerin	ACTIVE MOIETY	G59M7S0WS3	NITROGLYCERIN INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]	3
nitroglycerin	ACTIVE MOIETY	G59M7S0WS3	NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-4810	NITROGLYCERIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20210723_8c52cdf6-87be-4719-b105-f08be096d462.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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitroglycerin	NITROGLYCERIN	Henry Schein, Inc.	578d8159-5ec6-457f-b4a8-9add624d43a8	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072034 application number: ANDA072034
Nitroglycerin	NITROGLYCERIN	REMEDYREPACK INC.	b8af0974-33ea-4dd5-9ff7-3b61272aeb25	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072034 application number: ANDA072034
NITROGLYCERIN	NITROGLYCERIN	HF Acquisition Co LLC, DBA HealthFirst	9453bd8b-5d54-5dc8-e053-2995a90a95b2	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072034 application number: ANDA072034
Nitroglycerin	NITROGLYCERIN	American Regent, Inc.	8c52cdf6-87be-4719-b105-f08be096d462	2021-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072034 application number: ANDA072034 ndc (product): 0517-4810

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G59M7S0WS3	NITROGLYCERIN	55-63-0	NITROGLYCERIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
237205	nitroglycerin 50 MG in 10 ML Injection	PSN	8c52cdf6-87be-4719-b105-f08be096d462	7
237205	10 ML nitroglycerin 5 MG/ML Injection	SCD	8c52cdf6-87be-4719-b105-f08be096d462	7
237205	10 ML NTG 5 MG/ML Injection	SY	8c52cdf6-87be-4719-b105-f08be096d462	7
237205	10 ML TNG 5 MG/ML Injection	SY	8c52cdf6-87be-4719-b105-f08be096d462	7
237205	nitroglycerin 50 MG per 10 ML Injection	SY	8c52cdf6-87be-4719-b105-f08be096d462	7
237205	nitroglycerin 50 MG in 10 ML Injection	PSN	578d8159-5ec6-457f-b4a8-9add624d43a8	6
237205	10 ML nitroglycerin 5 MG/ML Injection	SCD	578d8159-5ec6-457f-b4a8-9add624d43a8	6
237205	10 ML NTG 5 MG/ML Injection	SY	578d8159-5ec6-457f-b4a8-9add624d43a8	6
237205	10 ML TNG 5 MG/ML Injection	SY	578d8159-5ec6-457f-b4a8-9add624d43a8	6
237205	nitroglycerin 50 MG per 10 ML Injection	SY	578d8159-5ec6-457f-b4a8-9add624d43a8	6
237205	nitroglycerin 50 MG in 10 ML Injection	PSN	9453bd8b-5d54-5dc8-e053-2995a90a95b2	5
237205	10 ML nitroglycerin 5 MG/ML Injection	SCD	9453bd8b-5d54-5dc8-e053-2995a90a95b2	5
237205	10 ML NTG 5 MG/ML Injection	SY	9453bd8b-5d54-5dc8-e053-2995a90a95b2	5
237205	10 ML TNG 5 MG/ML Injection	SY	9453bd8b-5d54-5dc8-e053-2995a90a95b2	5
237205	nitroglycerin 50 MG per 10 ML Injection	SY	9453bd8b-5d54-5dc8-e053-2995a90a95b2	5
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 table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-4810-01	00517481001	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
0517-4810-25	00517481025	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4810-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-4810-01)		2003-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitroglycerin 5 mg/mL Injection USP 10 mL Single Dose Vial	Henry Schein, Inc.	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	6
NITROGLYCERIN INJECTION, USP	REMEDYREPACK INC.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	2
NITROGLYCERIN INJECTION, USP 50mg/10mL (5mg/mL) 10mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2025-06-16	HUMAN PRESCRIPTION DRUG LABEL	5
Nitroglycerin 5 mg/mL Injection USP 10 mL Single Dose Vial	General Injectables and Vaccines, Inc.	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL	9
NITROGLYCERIN INJECTION, USP	American Regent, Inc.	2021-07-22	HUMAN PRESCRIPTION DRUG LABEL	7