Home NDC 52817-835-30 NITROGLYCERIN
Product NDC 52817-835
Requested package NDC 52817-835-30
11-digit product format 528170835
Labeler code 52817
Product ID 52817-835_28693a60-dc7a-eacb-e063-6394a90ae222
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitroglycerin
Dosage form OINTMENT
Route RECTAL
Labeler Trupharma, LLC
Application ANDA212222
Marketing category ANDA
Marketing start 2024-12-02
Substance NITROGLYCERIN
Active strength 4 mg/g
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212222-001 NITROGLYCERIN NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212222-001 AB
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 A212222-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212222-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212222-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212222-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212222-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212222-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212222-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212222-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-11-29 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1114466 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 52817-835-30 NITROGLYCERIN 1 in 1 CARTON OINTMENT 1 1 52817-835-30 NITROGLYCERIN 30 g in 1 TUBE OINTMENT 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52817-835 NITROGLYCERIN OINTMENT [TRUPHARMA, LLC] 1 Current NDC, 2 package rows 20241206_543ef8c8-d520-461b-bf6e-f8d8c277feec.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52817-835-30 52817083530 1 TUBE in 1 CARTON (52817-835-30) / 30 g in 1 TUBE 1 tube 2024-12-02 No No Current