Home NDC 42747-235-30 Rectiv
Product NDC 42747-235
Requested package NDC 42747-235-30
11-digit product format 427470235
Labeler code 42747
Product ID 42747-235_7b31d7ae-a9d3-737b-e053-2991aa0a70cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nitroglycerin
Dosage form OINTMENT
Route RECTAL
Labeler ProStrakan, Inc.
Application NDA021359
Marketing category NDA
Marketing start 2011-06-21
Marketing end 0000-00-00
Substance NITROGLYCERIN
Active strength 4 mg/g
Pharmacologic classes Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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date N021359-001 RECTIV NITROGLYCERIN 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / INTRA-ANAL RLD 2011-06-21
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 · 42 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 2026-08-18 06:07:40 2026-07 N021359-001 RECTIV 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / INTRA-ANAL RLD 2011-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL AB RLD, RS 2011-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021359-001 RECTIV 0.4% OINTMENT / INTRA-ANAL RLD, RS 2011-06-21 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rectiv NITROGLYCERIN Allergan, Inc. 603aa9ed-54c4-4a35-ade4-690fa44850e4 2024-07-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 021359 application number: NDA021359
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42747-235-30 42747023530 1 TUBE in 1 CARTON (42747-235-30) > 30 g in 1 TUBE 1 tube 2011-06-21 0000-00-00 No No Current