Home NDC 59762-4921 NITROGLYCERIN
Product NDC 59762-4921
11-digit product format 597624921
Labeler code 59762
Product ID 59762-4921_2ac009f2-257f-4603-a1e8-c50aa9e31f4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitroglycerin
Dosage form TABLET
Route SUBLINGUAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021134
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-08-26
Substance NITROGLYCERIN
Active strength .3 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 N021134-001 NITROSTAT NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 N021134-002 NITROSTAT NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 N021134-003 NITROSTAT NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01
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 4 · 123 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 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021134-002 NITROSTAT 0.4MG TABLET / SUBLINGUAL AB RLD 2000-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021134-003 NITROSTAT 0.6MG TABLET / SUBLINGUAL AB RLD, RS 2000-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021134-001 NITROSTAT 0.3MG TABLET / SUBLINGUAL AB RLD 2000-05-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 .3 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 59762-4921-1 NITROGLYCERIN 100 in 1 BOTTLE, GLASS TABLET 100 15 59762-4921-1 NITROGLYCERIN 1 in 1 CARTON TABLET 1 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-4921 NITROGLYCERIN TABLET [MYLAN PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 2 package rows 20250503_041f127e-5166-4484-bc1a-0a373d1187ae.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59762-4921-1 59762492101 1 BOTTLE, GLASS in 1 CARTON (59762-4921-1) / 100 TABLET in 1 BOTTLE, GLASS 2016-08-26 0000-00-00 No No Current