Home NDC 70710-1626 balsalazide disodium
Product NDC 70710-1626
11-digit product format 707101626
Labeler code 70710
Product ID 70710-1626_5364926a-5a07-440a-a27e-1435a9e4d4f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name balsalazide disodium
Dosage form CAPSULE
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA217592
Marketing category ANDA
Marketing start 2023-08-25
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 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 A217592-001 BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217592-001 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 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217592-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2023-06-08 a50c72e98297…
Observed Orange Book normalized TE history# 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 70710-1626-1 balsalazide disodium 280 in 1 BOTTLE CAPSULE 280 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1626 BALSALAZIDE DISODIUM CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.] 3 Current NDC, 1 package rows 20240330_0ed73067-e2ca-4184-a93a-5a2141bb4898.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 · 2 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 70710-1626-1 70710162601 280 CAPSULE in 1 BOTTLE (70710-1626-1) 280 capsule 2023-08-25 No No Current