Home NDC 0054-0079 Balsalazide Disodium
Product NDC 0054-0079
11-digit product format 000540079
Labeler code 0054
Product ID 0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Balsalazide Disodium
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA077806
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 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 A077806-001 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 A077806-001 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 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077806-001 BALSALAZIDE DISODIUM 750MG CAPSULE / ORAL AB 2007-12-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 0054-0079-28 Balsalazide Disodium 280 in 1 BOTTLE CAPSULE 280 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BALSALAZIDE DISODIUM ACTIVE INGREDIENT 1XL6BJI034 BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 BALSALAZIDE ACTIVE MOIETY P80AL8J7ZP BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 AMMONIA INACTIVE INGREDIENT 5138Q19F1X BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 GELATIN INACTIVE INGREDIENT 2G86QN327L BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 SHELLAC INACTIVE INGREDIENT 46N107B71O BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BALSALAZIDE DISODIUM CAPSULE [ROXANE LABORATORIES, INC] 5 BALSALAZIDE DISODIUM ACTIVE INGREDIENT 1XL6BJI034 BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 BALSALAZIDE ACTIVE MOIETY P80AL8J7ZP BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BALSALAZIDE DISODIUM CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0079 BALSALAZIDE DISODIUM CAPSULE [HIKMA PHARMACEUTICALS USA INC.] 12 Current NDC, Legacy NDC, 1 package rows 20240507_a0498308-14b2-4456-8e13-795f6fc8ea30.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 0054-0079-28 00054007928 280 CAPSULE in 1 BOTTLE (0054-0079-28) 280 capsule 2007-12-28 0000-00-00 No No Current