FDA.reportPublic FDA data

NITROGLYCERIN IN DEXTROSE

Product NDC
51662-1332
11-digit product format
516621332
Labeler code
51662
Product ID
51662-1332_ef6d3bae-5390-440c-e053-2995a90a3a9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN, DEXTROSE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA019970
Marketing category
NDA
Marketing start
2018-11-26
Substance
NITROGLYCERIN
Active strength
20 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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019970-001NITROGLYCERIN IN DEXTROSE 5%NITROGLYCERIN10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29
N019970-002NITROGLYCERIN IN DEXTROSE 5%NITROGLYCERIN20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29
N019970-003NITROGLYCERIN IN DEXTROSE 5%NITROGLYCERIN40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019970-002NITROGLYCERIN IN DEXTROSE 5%20MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019970-003NITROGLYCERIN IN DEXTROSE 5%40MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019970-001NITROGLYCERIN IN DEXTROSE 5%10MG/100MLINJECTABLE / INJECTIONRLD, RS1989-12-291e350fbaab3a…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019970-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019970-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019970-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019970-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019970-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019970-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019970-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019970-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019970-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019970-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019970-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019970-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019970-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019970-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019970-003AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019970-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N019970-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N019970-003AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019970-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019970-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019970-003AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019970-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019970-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019970-003AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019970-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019970-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019970-003AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019970-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019970-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019970-003AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019970-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N019970-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N019970-003AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019970-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N019970-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N019970-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019970-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07N019970-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07N019970-003AP1ea99ee380514…
2023-05-13 08:27 UTC2023-05N019970-001AP1053a50430f4f…

Additional Listing Data#

Finished product
Yes
Brand name base
NITROGLYCERIN IN DEXTROSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN20 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G59M7S0WS3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312004Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b98d1fc-44b2-08a1-e053-2991aa0af3abAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
00358076-c817-430b-b924-11d717dc307cProduct name120160718
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1332-12020-02-07C16284748780-19d75b9d0-a984-f424-e053-dadaa90a57ceNITROGLYCERIN IN 5% DEXTROSE INJECTION 50mg PER 250mL VIAL
51662-1332-12020-01-31C16284748780-19d75b9d0-a984-f424-e053-dadaa90a57ceNITROGLYCERIN IN 5% DEXTROSE INJECTION 50mg PER 250mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1332-1NITROGLYCERIN IN DEXTROSE250 mL in 1 BOTTLE, GLASSINJECTION2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1332NITROGLYCERIN IN DEXTROSE (NITROGLYCERIN, DEXTROSE) INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 1 package rows20221211_7b98d1fc-44b2-08a1-e053-2991aa0af3ab.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitroglycerin In DextroseNITROGLYCERINProPharma Distribution3f2c9570-a544-1982-e063-6294a90a30672025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 019970
application number: NDA019970
NITROGLYCERIN IN DEXTROSENITROGLYCERIN, DEXTROSEHF Acquisition Co LLC, DBA HealthFirst7b98d1fc-44b2-08a1-e053-2991aa0af3ab2022-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 019970
application number: NDA019970
ndc (product): 51662-1332
Nitroglycerin In DextroseNITROGLYCERINBaxter Healthcare Company457a026c-ebce-4701-9deb-2d7652759a992016-08-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 019970
application number: NDA019970

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312004nitroglycerin 50 MG in 250 ML InjectionPSN7b98d1fc-44b2-08a1-e053-2991aa0af3ab4
312004250 ML nitroglycerin 0.2 MG/ML InjectionSCD7b98d1fc-44b2-08a1-e053-2991aa0af3ab4
312004250 ML NTG 0.2 MG/ML InjectionSY7b98d1fc-44b2-08a1-e053-2991aa0af3ab4
312004250 ML TNG 0.2 MG/ML InjectionSY7b98d1fc-44b2-08a1-e053-2991aa0af3ab4
312004nitroglycerin 200 MCG/ML per 250 ML InjectionSY7b98d1fc-44b2-08a1-e053-2991aa0af3ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1332-151662133201250 mL in 1 BOTTLE, GLASS (51662-1332-1) 250 ml2018-11-260000-00-00NoNoCurrent