Nitroglycerin In Dextrose

Product NDC: 0338-1047
Requested package NDC: 0338-1047-02
11-digit product format: 003381047
Labeler code: 0338
Product ID: 0338-1047_b89cb9ff-d275-465b-b70b-d8e2e9406435
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitroglycerin
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
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: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0338-1047	0338-1047-02	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019970-001	NITROGLYCERIN IN DEXTROSE 5%	10MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019970-002	NITROGLYCERIN IN DEXTROSE 5%	20MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019970-003	NITROGLYCERIN IN DEXTROSE 5%	40MG/100ML	INJECTABLE / INJECTION	RLD, RS	1989-12-29	`caaa826d4ba7…`
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…`

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…`

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 In Dextrose
Listing expiration: 2027-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312004	Internal RxNorm lookup
1868494	Internal RxNorm lookup
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
457a026c-ebce-4701-9deb-2d7652759a99	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0338-1047-02	2022-12-09	C162847	48780-1	e4f33bdf-ae99-d8a0-e053-dadaa90a6e4e	Nitroglycerin in 5% Dextrose Injection For intravenous use only
0338-1047-02	2022-07-29	C162847	48780-1	e4f33bdf-ae99-d8a0-e053-dadaa90a6e4e	Nitroglycerin in 5% Dextrose Injection For intravenous use only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-1047-02	Nitroglycerin In Dextrose	250 mL in 1 BOTTLE, GLASS	INJECTION	250		14
0338-1047-02	Nitroglycerin In Dextrose	12 in 1 BOX	INJECTION	12		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1047-02	ML - Milliliter	0338-1047	14e3225e-5e4d-4c69-a473-d3df46046bd6	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NITROGLYCERIN	ACTIVE INGREDIENT	G59M7S0WS3	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4
NITROGLYCERIN	ACTIVE MOIETY	G59M7S0WS3	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-1047	NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN) INJECTION [BAXTER HEALTHCARE COMPANY]	13	Current NDC, Legacy NDC, 2 package rows	20250514_457a026c-ebce-4701-9deb-2d7652759a99.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 · 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
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 ndc (package): 0338-1047-02 ndc (product): 0338-1047 ndc11 (package): 00338104702

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
1868494	nitroglycerin 100 MG in 250 ML Injection	PSN	457a026c-ebce-4701-9deb-2d7652759a99	14
1868562	nitroglycerin 25 MG in 250 ML Injection	PSN	457a026c-ebce-4701-9deb-2d7652759a99	14
312004	nitroglycerin 50 MG in 250 ML Injection	PSN	457a026c-ebce-4701-9deb-2d7652759a99	14
1868562	250 ML nitroglycerin 0.1 MG/ML Injection	SCD	457a026c-ebce-4701-9deb-2d7652759a99	14
312004	250 ML nitroglycerin 0.2 MG/ML Injection	SCD	457a026c-ebce-4701-9deb-2d7652759a99	14
1868494	250 ML nitroglycerin 0.4 MG/ML Injection	SCD	457a026c-ebce-4701-9deb-2d7652759a99	14
1868562	250 ML NTG 0.1 MG/ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
312004	250 ML NTG 0.2 MG/ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
1868494	250 ML NTG 0.4 MG/ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
1868562	250 ML TNG 0.1 MG/ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
312004	250 ML TNG 0.2 MG/ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
1868494	250 ML TNG 0.4 MG/ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
1868494	nitroglycerin 100 MG per 250 ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
312004	nitroglycerin 200 MCG/ML per 250 ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
1868562	nitroglycerin 25 MG per 250 ML Injection	SY	457a026c-ebce-4701-9deb-2d7652759a99	14
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	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-1047-02	00338104702	12 BOTTLE, GLASS in 1 BOX (0338-1047-02) / 250 mL in 1 BOTTLE, GLASS	1989-12-29	0000-00-00	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
Nitroglycerin in 5% Dextrose Injection For intravenous use only	Baxter Healthcare Company \| Baxter Healthcare Corporation	2016-08-22	HUMAN PRESCRIPTION DRUG LABEL	14