Home NDC 0185-0757 Sulfadiazine
Product NDC 0185-0757
11-digit product format 001850757
Labeler code 0185
Product ID 0185-0757_4435aed7-872c-4439-b5d7-4abd212f4a1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfadiazine
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA040091
Marketing category ANDA
Marketing start 1994-07-29
Marketing end 2024-05-31
Substance SULFADIAZINE
Active strength 500 mg/1
Pharmacologic classes Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 50 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0185-0757-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0185-0757-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0185-0757-30 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0185-0757-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0185-0757-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0185-0757-30 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0185-0757-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0185-0757-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0185-0757-30 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0185-0757-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0185-0757-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0185-0757-30 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0185-0757-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0185-0757-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0185-0757-30 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0185-0757-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0185-0757-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0185-0757-30 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0185-0757-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0185-0757-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0185-0757-30 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0185-0757-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0185-0757-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0185-0757-30 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0185-0757-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0185-0757-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0185-0757-30 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0185-0757-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0185-0757-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0185-0757-30 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0185-0757-10 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0185-0757-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0185-0757-30 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0185-0757-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0185-0757-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0185-0757-30 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0185-0757-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 A040091-001 SULFADIAZINE SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29
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 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFADIAZINE ACTIVE INGREDIENT 0N7609K889 SULFADIAZINE TABLET [EON LABS, INC.] 14 SULFADIAZINE ACTIVE MOIETY 0N7609K889 SULFADIAZINE TABLET [EON LABS, INC.] 14 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULFADIAZINE TABLET [EON LABS, INC.] 14 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SULFADIAZINE TABLET [EON LABS, INC.] 14 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 SULFADIAZINE TABLET [EON LABS, INC.] 14 POVIDONE INACTIVE INGREDIENT FZ989GH94E SULFADIAZINE TABLET [EON LABS, INC.] 14 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SULFADIAZINE TABLET [EON LABS, INC.] 14 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SULFADIAZINE TABLET [EON LABS, INC.] 14 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SULFADIAZINE TABLET [EON LABS, INC.] 14
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0185-0757-01 00185075701 100 TABLET in 1 BOTTLE (0185-0757-01) 100 tablet 1994-07-29 2024-05-31 No No Current