Nitroglycerin In Dextrose

Product NDC: 84549-147
11-digit product format: 845490147
Labeler code: 84549
Product ID: 84549-147_463f0065-75fa-2d44-e063-6394a90a618b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: ProPharma Distribution
Application: NDA019970
Marketing category: NDA
Marketing start: 1989-12-29
Substance: NITROGLYCERIN
Active strength: 10 mg/100mL
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019970-001	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29
N019970-002	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29
N019970-003	NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29

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 4 · 123 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	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019970-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019970-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019970-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019970-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019970-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019970-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019970-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019970-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019970-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019970-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019970-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019970-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019970-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019970-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019970-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019970-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019970-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019970-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019970-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019970-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019970-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019970-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019970-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019970-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019970-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019970-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019970-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019970-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019970-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019970-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019970-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019970-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019970-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019970-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019970-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019970-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019970-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019970-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019970-003	AP	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N019970-001	AP	1	`053a50430f4f…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROGLYCERIN	10 mg/100mL

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
1868562	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
3f2c9570-a544-1982-e063-6294a90a3067	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
00358076-c817-430b-b924-11d717dc307c	Product name	1	20160718
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
84549-147-02	Nitroglycerin In Dextrose	250 mL in 1 BOTTLE, GLASS	INJECTION	250		2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitroglycerin In Dextrose	NITROGLYCERIN	ProPharma Distribution	3f2c9570-a544-1982-e063-6294a90a3067	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019970 application number: NDA019970 ndc (product): 84549-147
NITROGLYCERIN IN DEXTROSE	NITROGLYCERIN, DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	7b98d1fc-44b2-08a1-e053-2991aa0af3ab	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019970 application number: NDA019970
Nitroglycerin In Dextrose	NITROGLYCERIN	Baxter Healthcare Company	457a026c-ebce-4701-9deb-2d7652759a99	2016-08-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019970 application number: NDA019970

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
1868562	nitroglycerin 25 MG in 250 ML Injection	PSN	3f2c9570-a544-1982-e063-6294a90a3067	2
1868562	250 ML nitroglycerin 0.1 MG/ML Injection	SCD	3f2c9570-a544-1982-e063-6294a90a3067	2
1868562	250 ML NTG 0.1 MG/ML Injection	SY	3f2c9570-a544-1982-e063-6294a90a3067	2
1868562	250 ML TNG 0.1 MG/ML Injection	SY	3f2c9570-a544-1982-e063-6294a90a3067	2
1868562	nitroglycerin 25 MG per 250 ML Injection	SY	3f2c9570-a544-1982-e063-6294a90a3067	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-147-02	84549014702	250 mL in 1 BOTTLE, GLASS (84549-147-02)	250 ml	2025-10-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitroglycerin in 5% Dextrose Injection For intravenous use only	ProPharma Distribution	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	2