Home NDC 50090-8160 NITROGLYCERIN
Product NDC 50090-8160
11-digit product format 500908160
Labeler code 50090
Product ID 50090-8160_5d99ab30-1b61-40ab-93ed-36fecf910f74
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NITROGLYCERIN
Dosage form TABLET
Route SUBLINGUAL
Labeler A-S Medication Solutions
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 66 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 2026-10-15 13:18:30 2026-09 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217879-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217879-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2023-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217879-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2023-10-26 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base NITROGLYCERIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROGLYCERIN .4 mg/1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8160-0 50090816000 4 BOTTLE in 1 CARTON (50090-8160-0) / 25 TABLET in 1 BOTTLE 4 bottle 2026-10-21 No No Current