NITROGLYCERIN

Product NDC
51662-1282
11-digit product format
516621282
Labeler code
51662
Product ID
51662-1282_2b37f407-bc60-6054-e063-6394a90ada02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA208191
Marketing category
ANDA
Marketing start
2021-05-11
Substance
NITROGLYCERIN
Active strength
.4 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51662-1282IInactivated by FDA2026-08-11
excluded packagepackage51662-128251662-1282-1IInactivated by FDA2026-08-11

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51662-1282-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51662-1282-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51662-1282-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51662-1282-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51662-1282-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51662-1282-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51662-1282-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51662-1282-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51662-1282-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208191-001NITROGLYCERINNITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26
A208191-002NITROGLYCERINNITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26
A208191-003NITROGLYCERINNITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208191-001AB
A208191-002AB
A208191-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208191-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208191-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208191-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208191-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208191-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208191-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208191-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208191-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208191-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208191-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208191-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208191-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208191-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208191-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208191-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208191-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208191-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208191-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208191-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208191-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208191-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208191-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.4 mg/1

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
198039Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c20e89b4-57b5-259d-e053-2a95a90a0038Available 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
00358076-c817-430b-b924-11d717dc307cProduct name120160718
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1282-2NITROGLYCERIN1 in 1 POUCHTABLET16
51662-1282-2NITROGLYCERIN25 in 1 BOTTLETABLET256
51662-1282-3NITROGLYCERIN24 in 1 BOXTABLET246
51662-1282-1NITROGLYCERIN25 in 1 BOTTLETABLET253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1282NITROGLYCERIN TABLET [HF ACQUISITION CO LLC, DBA HEALTHFIRST]6Current NDC, Legacy NDC, 3 package rows20250110_c20e89b4-57b5-259d-e053-2a95a90a0038.zip
51662-1282NITROGLYCERIN TABLET [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20200222_763ce792-c991-f472-e053-2a91aa0a77dd.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitroglycerinNITROGLYCERINGolden State Medical Supply, Inc.df52ab34-e44c-46f3-8c44-2c1bcb93f28e2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
NitroglycerinNITROGLYCERINDr. Reddys Laboratories Incc555f8de-477f-0225-98a2-baf8945bbd632026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstc20e89b4-57b5-259d-e053-2a95a90a00382025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
ndc (product): 51662-1282
NitroglycerinNITROGLYCERINA-S Medication Solutionsfc297c0a-a412-40be-8414-4bf9906fd3002023-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC6671d89f-cc89-c03c-e053-2a91aa0aa5fa2023-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
NitroglycerinNITROGLYCERINProficient Rx LP67a15ee9-a6ae-4a60-8333-e06c608cfd712022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSNc20e89b4-57b5-259d-e053-2a95a90a00386
198039nitroglycerin 0.4 MG Sublingual TabletSCDc20e89b4-57b5-259d-e053-2a95a90a00386
198039nitroglycerin 400 MCG Sublingual TabletSYc20e89b4-57b5-259d-e053-2a95a90a00386
198039NTG 0.4 MG Sublingual TabletSYc20e89b4-57b5-259d-e053-2a95a90a00386
198039TNG 0.4 MG Sublingual TabletSYc20e89b4-57b5-259d-e053-2a95a90a00386
198039nitroglycerin 0.4 MG Sublingual TabletPSN763ce792-c991-f472-e053-2a91aa0a77dd3
198039nitroglycerin 0.4 MG Sublingual TabletSCD763ce792-c991-f472-e053-2a91aa0a77dd3
198039nitroglycerin 400 MCG Sublingual TabletSY763ce792-c991-f472-e053-2a91aa0a77dd3
198039NTG 0.4 MG Sublingual TabletSY763ce792-c991-f472-e053-2a91aa0a77dd3
198039TNG 0.4 MG Sublingual TabletSY763ce792-c991-f472-e053-2a91aa0a77dd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1282-15166212820125 TABLET in 1 BOTTLE (51662-1282-1) 25 tablet2018-09-190000-00-00NoNoCurrent
51662-1282-2516621282021 in 1 POUCHHistorical
51662-1282-35166212820324 POUCH in 1 BOX (51662-1282-3) / 1 BOTTLE in 1 POUCH (51662-1282-2) / 25 TABLET in 1 BOTTLE24 pouch2021-05-110000-00-00NoNoCurrent