Home NDC 50090-7203 NITROSTAT
Product NDC 50090-7203
11-digit product format 500907203
Labeler code 50090
Product ID 50090-7203_d66cce9b-74ee-43e0-9e2e-e485be38209e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitroglycerin
Dosage form TABLET
Route SUBLINGUAL
Labeler A-S Medication Solutions
Application NDA021134
Marketing category NDA
Marketing start 2024-02-02
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 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 NITROSTAT
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198039 Internal RxNorm lookup 207346 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 50090-7203-0 NITROSTAT 25 in 1 BOTTLE TABLET 25 3 50090-7203-0 NITROSTAT 1 in 1 CARTON TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7203 NITROSTAT (NITROGLYCERIN) TABLET [A-S MEDICATION SOLUTIONS] 3 Current NDC, 2 package rows 20240806_f7059ff7-bf74-48b4-811d-6eb1c26bfd8b.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 Units Marketing start Sample Exclude flag Status 50090-7203-0 50090720300 1 BOTTLE in 1 CARTON (50090-7203-0) / 25 TABLET in 1 BOTTLE 1 bottle 2024-08-01 No No Current