Home NDC 24338-010 BiDil
Product NDC 24338-010
11-digit product format 243380010
Labeler code 24338
Product ID 24338-010_79524516-67d7-45ef-bf97-878c6dc8d6ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralazine hydrochloride and Isosorbide dinitrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA020727
Marketing category NDA
Marketing start 2012-12-05
Substance HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Active strength 37.5; 20 mg/1; mg/1
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 N020727-001 BIDIL HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020727-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL RLD, RS 2005-06-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020727-001 BIDIL 37.5MG;20MG TABLET / ORAL AB RLD, RS 2005-06-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Additional Listing Data#
Finished product Yes
Brand name base BiDil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDRALAZINE HYDROCHLORIDE 37.5 mg/1 ISOSORBIDE DINITRATE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FD171B778Y Internal UNII lookup IA7306519N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905377 Internal RxNorm lookup 905379 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 24338-010-09 BiDil 90 in 1 BOTTLE TABLET, FILM COATED 90 13 24338-010-12 BiDil 12 in 1 BOTTLE TABLET, FILM COATED 12 13 24338-010-18 BiDil 180 in 1 BOTTLE TABLET, FILM COATED 180 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydralazine hydrochloride ACTIVE INGREDIENT FD171B778Y BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 Isosorbide dinitrate ACTIVE INGREDIENT IA7306519N BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 Hydralazine ACTIVE MOIETY 26NAK24LS8 BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 Isosorbide dinitrate ACTIVE MOIETY IA7306519N BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 aluminum oxide INACTIVE INGREDIENT LMI26O6933 BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 FD&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [ARBOR PHARMACEUTICALS, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24338-010 BIDIL (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [AZURITY] 12 Current NDC, Legacy NDC, 3 package rows 20220721_e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 24338-010-09 24338001009 90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09) 2020-08-31 0000-00-00 No No Current 24338-010-12 24338001012 12 TABLET, FILM COATED in 1 BOTTLE (24338-010-12) 2012-12-05 2022-01-31 No No Current 24338-010-18 24338001018 180 TABLET, FILM COATED in 1 BOTTLE (24338-010-18) 2012-12-05 0000-00-00 No No Current