Home NDC 59651-658 NITROGLYCERIN
Product NDC 59651-658
11-digit product format 596510658
Labeler code 59651
Product ID 59651-658_26c314ea-077e-490b-826b-2aafcb6e9564
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NITROGLYCERIN
Dosage form TABLET
Route SUBLINGUAL
Labeler Aurobindo Pharma Limited
Application ANDA217879
Marketing category ANDA
Marketing start 2023-10-26
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217879-001 NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 A217879-002 NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 A217879-003 NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 · 57 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NITROGLYCERIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROGLYCERIN .4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G59M7S0WS3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198038 Internal RxNorm lookup 198039 Internal RxNorm lookup 198040 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-658-00 NITROGLYCERIN 1 in 1 CARTON TABLET 1 1 59651-658-00 NITROGLYCERIN 100 in 1 BOTTLE TABLET 100 1 59651-658-04 NITROGLYCERIN 4 in 1 CARTON TABLET 4 1 59651-658-04 NITROGLYCERIN 25 in 1 BOTTLE TABLET 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-658 NITROGLYCERIN TABLET [AUROBINDO PHARMA LIMITED] 1 Current NDC, 4 package rows 20231102_26c314ea-077e-490b-826b-2aafcb6e9564.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-658-00 59651065800 1 BOTTLE in 1 CARTON (59651-658-00) / 100 TABLET in 1 BOTTLE 1 bottle 2023-10-26 No No Current 59651-658-04 59651065804 4 BOTTLE in 1 CARTON (59651-658-04) / 25 TABLET in 1 BOTTLE 4 bottle 2023-10-26 No No Current