Home NDC 0713-0564 NITROGLYCERIN
Product NDC 0713-0564
11-digit product format 007130564
Labeler code 0713
Product ID 0713-0564_11e6d0dd-d89a-7551-e063-6394a90a16ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitroglycerin
Dosage form OINTMENT
Route RECTAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA216103
Marketing category ANDA
Marketing start 2024-02-23
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 A216103-001 NITROGLYCERIN NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB RS 2024-02-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216103-001 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 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB 2024-02-16 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216103-001 NITROGLYCERIN 0.4% OINTMENT / INTRA-ANAL AB RS 2024-02-16 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216103-001 CGT 2024-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216103-001 CGT 2024-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216103-001 CGT 2024-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216103-001 CGT 2024-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216103-001 CGT 2024-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216103-001 CGT 2024-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216103-001 CGT 2024-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216103-001 CGT 2024-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216103-001 CGT 2024-08-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216103-001 CGT 2024-08-21 6a51e52b5d6a…
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 0713-0564-31 NITROGLYCERIN 30 g in 1 TUBE OINTMENT 30 1 0713-0564-31 NITROGLYCERIN 1 in 1 CARTON OINTMENT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0564 NITROGLYCERIN OINTMENT [COSETTE PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20240224_ac908e70-9425-4e9c-8c67-7b2882b40204.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 · 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 0713-0564-31 00713056431 1 TUBE in 1 CARTON (0713-0564-31) / 30 g in 1 TUBE 1 tube 2024-02-23 No No Current