FDA.reportPublic FDA data

Nitroglycerin

Product NDC
43598-435
Requested package NDC
43598-435-01
11-digit product format
435980435
Labeler code
43598
Product ID
43598-435_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
.3 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208191-001NITROGLYCERIN0.3MGTABLET / SUBLINGUALAB2016-08-26a50c72e98297…
2026-08-01 22:54:322026-06A208191-002NITROGLYCERIN0.4MGTABLET / SUBLINGUALAB2016-08-26a50c72e98297…
2026-08-01 22:54:322026-06A208191-003NITROGLYCERIN0.6MGTABLET / SUBLINGUALAB2016-08-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208191-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208191-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208191-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 43598-435-01
ndc (product): 43598-435
ndc11 (package): 43598043501
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.3 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
43598-435-01Nitroglycerin100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-435-01EA - Each43598-435dd949525-2e0e-4d35-8c2e-caa9f297ccc712016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-435NITROGLYCERIN TABLET [DR. REDDYS LABORATORIES INC]5Current NDC, Legacy NDC, 1 package rows20170412_c555f8de-477f-0225-98a2-baf8945bbd63.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-435-0143598043501100 TABLET in 1 BOTTLE (43598-435-01) 100 tablet2016-08-290000-00-00NoNoCurrent