Nitroglycerin

Product NDC
43598-437
Requested package NDC
43598-437-01
11-digit product format
435980437
Labeler code
43598
Product ID
43598-437_b6f146c9-be21-75da-dc27-e968a5f760ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA208191
Marketing category
ANDA
Marketing start
2016-08-29
Substance
NITROGLYCERIN
Active strength
.6 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
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.6 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198038Internal RxNorm lookup
198039Internal RxNorm lookup
198040Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c555f8de-477f-0225-98a2-baf8945bbd63Available 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
43598-437-01Nitroglycerin100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-437-01EA - Each43598-437443e757c-50cf-4fe5-a677-94bdc507a63e12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-437NITROGLYCERIN TABLET [DR. REDDYS LABORATORIES INC]5Current NDC, Legacy NDC, 1 package rows20170412_c555f8de-477f-0225-98a2-baf8945bbd63.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
ndc (package): 43598-437-01
ndc (product): 43598-437
ndc11 (package): 43598043701
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirstc20e89b4-57b5-259d-e053-2a95a90a00382025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208191
application number: ANDA208191
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
198038nitroglycerin 0.3 MG Sublingual TabletPSNc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 0.4 MG Sublingual TabletPSNc555f8de-477f-0225-98a2-baf8945bbd636
198040nitroglycerin 0.6 MG Sublingual TabletPSNc555f8de-477f-0225-98a2-baf8945bbd636
198038nitroglycerin 0.3 MG Sublingual TabletSCDc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 0.4 MG Sublingual TabletSCDc555f8de-477f-0225-98a2-baf8945bbd636
198040nitroglycerin 0.6 MG Sublingual TabletSCDc555f8de-477f-0225-98a2-baf8945bbd636
198038nitroglycerin 300 MCG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039nitroglycerin 400 MCG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198040nitroglycerin 600 MCG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198038NTG 0.3 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039NTG 0.4 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198040NTG 0.6 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198038TNG 0.3 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198039TNG 0.4 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198040TNG 0.6 MG Sublingual TabletSYc555f8de-477f-0225-98a2-baf8945bbd636
198038nitroglycerin 0.3 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 0.4 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 0.6 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038nitroglycerin 0.3 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 0.4 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 0.6 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038nitroglycerin 300 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 400 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 600 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038NTG 0.3 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039NTG 0.4 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040NTG 0.6 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038TNG 0.3 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039TNG 0.4 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040TNG 0.6 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 0.6 MG Sublingual TabletPSN1e1d0b0e-a963-4629-e063-6294a90a90ba1
198040nitroglycerin 0.6 MG Sublingual TabletSCD1e1d0b0e-a963-4629-e063-6294a90a90ba1
198040nitroglycerin 600 MCG Sublingual TabletSY1e1d0b0e-a963-4629-e063-6294a90a90ba1
198040NTG 0.6 MG Sublingual TabletSY1e1d0b0e-a963-4629-e063-6294a90a90ba1
198040TNG 0.6 MG Sublingual TabletSY1e1d0b0e-a963-4629-e063-6294a90a90ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-437-0143598043701100 TABLET in 1 BOTTLE (43598-437-01) 100 tablet2016-08-290000-00-00NoNoCurrent