Home NDC 83112-400 Cefixime 400 mg
Product NDC 83112-400
11-digit product format 831120400
Labeler code 83112
Product ID 83112-400_466300ca-f48d-6568-e063-6294a90ac2a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefixime
Dosage form CAPSULE
Route ORAL
Labeler Health Department, Oklahoma State
Application ANDA210574
Marketing category ANDA
Marketing start 2018-10-12
Substance CEFIXIME
Active strength 400 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [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 A210574-001 CEFIXIME CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210574-001 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 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210574-001 CEFIXIME 400MG CAPSULE / ORAL RS 2018-10-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210574-001 CEFIXIME 400MG CAPSULE / ORAL AB 2018-10-09 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cefixime 400 mg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFIXIME 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 97I1C92E55 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 409823 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 83112-400-00 Cefixime 400 mg 2 in 1 PACKET CAPSULE 2 3 83112-400-02 Cefixime 400 mg 2 in 1 PACKET CAPSULE 2 3
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 Sample Exclude flag Status 83112-400-00 83112040000 2 CAPSULE in 1 PACKET (83112-400-00) 2 capsule 2018-10-12 No No Current 83112-400-02 83112040002 2 CAPSULE in 1 PACKET (83112-400-02) 2 capsule 2018-10-12 No No Current