Home NDC 51662-1393-1 NITROGLYCERIN LINGUAL
Product NDC 51662-1393
Requested package NDC 51662-1393-1
11-digit product format 516621393
Labeler code 51662
Product ID 51662-1393_2b37a91d-601d-e96f-e063-6394a90a3e7a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NITROGLYCERIN LINGUAL
Dosage form SPRAY
Route ORAL
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA091496
Marketing category ANDA
Marketing start 2019-10-09
Substance NITROGLYCERIN
Active strength 400 ug/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091496-001 NITROGLYCERIN NITROGLYCERIN 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB 2013-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091496-001 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 2026-08-01 22:54:32 2026-06 A091496-001 NITROGLYCERIN 0.4MG/SPRAY SPRAY, METERED / SUBLINGUAL AB 2013-09-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A091496-001 AB 1 a50c72e98297…
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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base NITROGLYCERIN LINGUAL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROGLYCERIN 400 ug/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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 705129 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 51662-1393-1 NITROGLYCERIN LINGUAL 60 in 1 BOTTLE SPRAY 60 3 51662-1393-1 NITROGLYCERIN LINGUAL 1 in 1 CARTON SPRAY 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1393 NITROGLYCERIN LINGUAL SPRAY [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 2 package rows 20250110_947e4e68-ef8a-6c63-e053-2a95a90ac193.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51662-1393-1 51662139301 1 BOTTLE in 1 CARTON (51662-1393-1) / 60 SPRAY in 1 BOTTLE 1 bottle 2019-10-09 0000-00-00 No No Current