Home NDC 43547-985 Nitroglycerin
Product NDC 43547-985
11-digit product format 435470985
Labeler code 43547
Product ID 43547-985_6624eac6-c803-45d1-ad99-8ffa6c5a5ac9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitroglycerin
Dosage form TABLET
Route SUBLINGUAL
Labeler Solco Healthcare U.S., LLC
Application ANDA218583
Marketing category ANDA
Marketing start 2025-06-01
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 A218583-001 NITROGLYCERIN NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 A218583-002 NITROGLYCERIN NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 A218583-003 NITROGLYCERIN NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15
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.
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 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218583-001 NITROGLYCERIN 0.3MG TABLET / SUBLINGUAL AB 2024-10-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218583-002 NITROGLYCERIN 0.4MG TABLET / SUBLINGUAL AB 2024-10-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218583-003 NITROGLYCERIN 0.6MG TABLET / SUBLINGUAL AB 2024-10-15 a50c72e98297…
Observed Orange Book normalized TE history# 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 43547-985-04 Nitroglycerin 4 in 1 CARTON TABLET 4 3 43547-985-04 Nitroglycerin 25 in 1 BOTTLE TABLET 25 3 43547-985-10 Nitroglycerin 100 in 1 BOTTLE TABLET 100 3 43547-985-10 Nitroglycerin 1 in 1 CARTON TABLET 1 3
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 43547-985-04 43547098504 4 BOTTLE in 1 CARTON (43547-985-04) / 25 TABLET in 1 BOTTLE 4 bottle 2025-06-01 No No Current 43547-985-10 43547098510 1 BOTTLE in 1 CARTON (43547-985-10) / 100 TABLET in 1 BOTTLE 1 bottle 2025-06-01 No No Current