NITROGLYCERIN

Product NDC
51662-1676
11-digit product format
516621676
Labeler code
51662
Product ID
51662-1676_4d7b5803-e3c8-8937-e063-6394a90a8235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA209779
Marketing category
ANDA
Marketing start
2021-05-03
Substance
NITROGLYCERIN
Active strength
.4 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209779-001NITROGLYCERINNITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-03
A209779-002NITROGLYCERINNITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-03
A209779-003NITROGLYCERINNITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209779-001AB
A209779-002AB
A209779-003AB

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 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209779-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2021-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209779-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2021-05-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209779-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2021-05-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209779-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209779-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209779-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209779-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209779-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209779-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209779-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209779-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209779-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209779-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209779-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209779-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209779-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209779-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209779-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209779-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209779-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209779-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209779-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209779-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209779-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209779-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209779-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209779-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209779-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209779-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209779-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209779-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209779-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209779-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209779-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209779-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209779-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209779-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209779-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209779-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209779-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209779-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209779-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209779-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
NITROGLYCERIN
Listing expiration
2027-12-31

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
4b4667e9-3b5e-4dc0-e063-6394a90ac1f5Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1676-1NITROGLYCERIN25 in 1 BOTTLETABLET253
51662-1676-2NITROGLYCERIN1 in 1 POUCHTABLET13
51662-1676-3NITROGLYCERIN24 in 1 CASETABLET243

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
NitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC4e83a438-1ed6-0a86-e063-6294a90adc8c2026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209779
application number: ANDA209779
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst4b4667e9-3b5e-4dc0-e063-6394a90ac1f52026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209779
application number: ANDA209779
ndc (product): 51662-1676
NitroglycerinNITROGLYCERINAdvagen Pharma Ltd5a36dac2-7d35-4cbf-be3d-705b7135754d2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209779
application number: ANDA209779

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSN4b4667e9-3b5e-4dc0-e063-6394a90ac1f53
198039nitroglycerin 0.4 MG Sublingual TabletSCD4b4667e9-3b5e-4dc0-e063-6394a90ac1f53
198039nitroglycerin 400 MCG Sublingual TabletSY4b4667e9-3b5e-4dc0-e063-6394a90ac1f53
198039NTG 0.4 MG Sublingual TabletSY4b4667e9-3b5e-4dc0-e063-6394a90ac1f53
198039TNG 0.4 MG Sublingual TabletSY4b4667e9-3b5e-4dc0-e063-6394a90ac1f53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1676-15166216760125 in 1 BOTTLEHistorical
51662-1676-2516621676021 in 1 POUCHHistorical
51662-1676-35166216760324 POUCH in 1 CASE (51662-1676-3) / 1 BOTTLE in 1 POUCH (51662-1676-2) / 25 TABLET in 1 BOTTLE (51662-1676-1) 24 pouch2021-05-03NoNoCurrent