Home NDC 42806-757 SULFADIAZINE
Product NDC 42806-757
11-digit product format 428060757
Labeler code 42806
Product ID 42806-757_69f2d77c-8279-4524-93c2-f199e7973400
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulfadiazine
Dosage form TABLET
Route ORAL
Labeler EPIC PHARMA, LLC
Application ANDA040091
Marketing category ANDA
Marketing start 2021-12-15
Substance SULFADIAZINE
Active strength 500 mg/1
Pharmacologic classes Sulfonamide Antibacterial [EPC], Sulfonamides [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 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 · 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 A040091-001 SULFADIAZINE 500MG TABLET / ORAL RS 1994-07-29 caaa826d4ba7…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…
Additional Listing Data#
Finished product Yes
Brand name base SULFADIAZINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFADIAZINE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0N7609K889 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198228 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 42806-757-60 SULFADIAZINE 60 in 1 BOTTLE TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-757 SULFADIAZINE TABLET [EPIC PHARMA, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231221_8993651b-fff6-4e3f-9b60-78587bc9bcee.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 · 1 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 42806-757-60 42806075760 60 TABLET in 1 BOTTLE (42806-757-60) 60 tablet 2021-12-15 0000-00-00 No No Current