Home NDC 60505-2575 Balsalazide Disodium
Product NDC 60505-2575
11-digit product format 605052575
Labeler code 60505
Product ID 60505-2575_18469dde-9cd3-fbc8-40ba-8b17b6a9c07a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Balsalazide Disodium
Dosage form CAPSULE
Route ORAL
Labeler Apotex Corp.
Application ANDA077883
Marketing category ANDA
Marketing start 2007-12-28
Substance BALSALAZIDE DISODIUM
Active strength 750 mg/1
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
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 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 A077883-001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077883-001 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 · 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 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077883-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Balsalazide Disodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BALSALAZIDE DISODIUM 750 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1XL6BJI034 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 885857 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 60505-2575-0 Balsalazide Disodium 10 in 1 BLISTER PACK CAPSULE 10 14 60505-2575-0 Balsalazide Disodium 10 in 1 CARTON CAPSULE 10 14 60505-2575-3 Balsalazide Disodium 30 in 1 BOTTLE CAPSULE 30 14 60505-2575-4 Balsalazide Disodium 350 in 1 BOTTLE CAPSULE 350 14 60505-2575-7 Balsalazide Disodium 280 in 1 BOTTLE CAPSULE 280 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-2575 BALSALAZIDE DISODIUM CAPSULE [APOTEX CORP.] 14 Current NDC, Legacy NDC, 5 package rows 20250104_f12ffa32-d14b-e9d9-e957-2ef08b64e8b4.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 Units Marketing start Marketing end Sample Exclude flag Status 60505-2575-0 60505257500 10 BLISTER PACK in 1 CARTON (60505-2575-0) / 10 CAPSULE in 1 BLISTER PACK 10 blister pack 2007-12-28 0000-00-00 No No Current 60505-2575-3 60505257503 30 CAPSULE in 1 BOTTLE (60505-2575-3) 30 capsule 2007-12-28 0000-00-00 No No Current 60505-2575-4 60505257504 350 CAPSULE in 1 BOTTLE (60505-2575-4) 350 capsule 2007-12-28 0000-00-00 No No Current 60505-2575-7 60505257507 280 CAPSULE in 1 BOTTLE (60505-2575-7) 280 capsule 2007-12-28 0000-00-00 No No Current